TRUCKS

Choosing a truck is a very complex matter, which must always be discussed with your technical department.

A digital guide to help with the decision to "procure or rent" is available and allows, by going through different steps, to:

• process an analysis of your needs and the ability of your mission to manage and maintain a truck.
• decide between "procurement" or "rent" and in case of a choice to procure, between local procurement or international procurement (decision HQ).
• communicate between the field and head quarters about this topic
• capitalise on the analysis.

The digital guide is called "Truck Rent or Buy Analysis" and is available under the MSF tools and reference books in the digital catalogue and on SherLog.

Evaluation of needs, some guidance:

Begin by assessing your needs, answering the questions below as fully as possible, before considering possible solutions.

• When will the need for a truck begin?
• For how long?
• How many days per week?
• How many kilometres per week?
• For what kind of goods?
• What is the approximate payload needed?
• What is the approximate volume needed?
• How is the quality of the roads?
• What do other organizations do about transport?
• What is the fleet of trucks available locally regarding quantity, models, owners?
• Is it possible to use a local haulage contractor?
• Is it possible to rent a truck locally?
• Is it possible to share the transport capacity of other organisations?
• What type of truck do you need: a 4x2 or 4x4?
• Is it possible to buy a new or second-hand truck locally or regionally?
• What is the local availability of spare parts, and for which brands?
• Is it possible to recruit locally a good truck driver, a good driver's mate, and a good mechanic?
• Is there a good mechanical workshop in the area for repairs?
• Do you have the resources in terms of HR and materials to manage and maintain a truck?

The final decision should be taken between the operational section (mission and HQ) and the technical department.

An MSF truck allows for some flexibility and self-reliance in operations, while its management needs technical and HR means that should not be overlooked.

Contact your technical department to make the evaluation tool "procure or rent" available, for further discussions.

The procurement of a vehicle, either new or second-hand should always be discussed with your technical department and approved by them.

Possible solutions

• Contract with a local haulage firm

This is usually the best solution.

• Advantage: the haulage firm is responsible for the truck and for any problems occurring during transportation
• Disadvantage: less flexibility

A contract should be drawn up for each journey. This contract should clearly specify who is responsible for what with regards to loading and transportation.

For transport of sensitive or costly goods, or if there is a risk of theft, have an MSF staff member ride in the truck.

• Renting a truck locally

• Advantage: more flexibility
• Disadvantage: more work and more responsibilities for MSF

One contract should be adequate for all the journeys during the rental period.

This contract should clearly specify who is responsible for what with regards to the truck, its loading and the transportation.

Try to get the owner to assume responsibility for maintenance.

It is always preferable to rent a truck with a driver: although more expensive, this considerably reduces MSF's liability.

• Purchasing a truck

To be considered only as a last resort.

• advantage: more flexibility and independence
• disadvantages: significant investment, which will pay for itself only in the long term, and even then only if well managed (planning, maintenance, repairs, spare parts etc.)

It is essential to have a good and trustworthy truck driver, along with a driver's mate.

Of all the different possible options (new or second-hand truck, local or European purchase), buy a second-hand truck in Europe if you can. Avoid purchasing a second-hand truck locally.

Putting in place an adequate transport follow-up system is necessary to guarantee the security and operability of the material at a controlled cost.

The management of spare parts is quite complex.

In order to define the parts you need, you must first identify:

• the chassis type and number
• the engine type and number
• the year of assembly
• the front axle type and number
• the rear axle type and number
• the transfer box type and number (for 4x4)
• the gearbox type and number.

Finding part numbers in catalogues is a laborious task. However, if you give the suppliers the worn-out part and all the above information, they should be able to find the right part.

MANAGING THE VEHICLE FLEET

Vehicles are essential to the running of a project and must therefore be properly managed.

See the existing MSF guidelines on the subject.

The MSF set of documents that include guidelines and catalogues embody the collective experiences of medical and logistics technicians from all MSF sections, whose years of experience have been compiled with the aim of helping the field staff in their daily work, speed up our interventions, and standardize our practices.

1. GUIDELINES

The guidelines concerning methods and protocols for implementation were the first documents to be produced. They indicate the most effective way to face up to a problem in a limited resources environment. As their use is not exclusively reserved for MSF, they propose a wider selection than what is actually available in the field (e.g.: the MSF guidelines “essential drugs” mentions some products which are not used by MSF, but which are still used in some countries).

2. CATALOGUES (9 VOLUMES)

The catalogues are common to all MSF sections. They propose medical and non-medical products selected by the MSF referents as being the most suitable for a given situation. They are used as reference and technical support for missions and supply centres, as well as specifications for technicians, purchasers and persons in charge of articles’ quality control at reception.

• The LOGISTICS (1 volume) and MEDICAL (7 volumes) CATALOGUES constitute THE REFERENCE regarding the selection, the use, the maintenance and the storage of standard articles which are used in MSF missions.
• The KITS CATALOGUE (1 volume) allows for the planning and quantifying of emergency operations due to a description of the type of use and the detailed content of each kit.

Catalogues are updated during international working/contact group meetings and their content is validated by the medical directors of the five operational centres of MSF. They are bilingual (English/French)

The catalogues can be ordered together (as a set of 7 catalogues) or separately through your OC library focal point (Bibop).

3. PUBLISHING OF MSF DOCUMENTS

The international MSF guidelines are available through the international medical guidelines website
https://medicalguidelines.msf.org/viewport/MG/en/guidelines-16681097.html

Some international MSF guidelines are for internal use and only available for the MSF world. They are posted on the Sharepoint.https://msfintl.sharepoint.com/sites/msfintlcommunities/IGP

The catalogues are edited by SPINCO once a year. They are simultaneously published on paper, electronic format (memory key) and posted on the Intranet (Sharepoint), from the international masterdata platform, UniData, managed by SPINCO.https://msfintl.sharepoint.com/sites/msfintlcommunities/MSFCatalogues

Since 2021, the new platform UniCat is accessible on the web. It also enables to see the articles with their technical sheet/FFF. The advantages of UniCat are the daily updates and the ease of use.
https://unicat.msf.org/

The technical sheets, the Form Fit & Function (FFF) specifications and the photos of articles can also be viewed in UniData at any time.

The electronic version on Sharepoint also includes:

• the international MSF guidelines which are linked to the medical or logistic catalogues
• “Clinical guidelines”
• “Essential drugs”
• “Essential obstetric and newborn care”
• “Management of a cholera epidemic”
• “Management of a measles epidemic”
• “Tuberculosis”
• “Public health engineering in precarious situations”
• “Refugee health”
• “Temporary Health Structures”
• “Blood transfusion”
• “Management of epidemic meningococcal meningitis”
• “Rapid health assessment of refugee or displaced populations”
• “Integrating HIV & TB care in basic health care package in MSF projects”
• “Paediatric HIV Handbook”
• “Neonatal care. Clinical and therapeutic guidelines”
• "Mental Helath and Psychosocial Support Guideline"
• “Laboratory manual”
• "MSF laboratory quality assurance manual"
• "Collection, storage and transport of samples"
• “Electrical Installations and Equipment in the Field”
• “Ultrasound manual. For trained practioners”
• “X-ray manual. Guidelines for implementation and provision of x-ray services”
• the MSF TOOLS: pictures of the surgical sets, medical, food and logistical stationary forms, Excel file with kit contents, summary of changes and some logistical guides

4. FEEDBACK FROM THE FIELD

The MSF documents evolve for the most part thanks to continuous FEEDBACK from the field and from other users. Don’t hesitate to contact SPINCO (spinco.medical@msf.org or spinco.logistics@msf.org) to tell us about your experience !

1. VISION

SPINCO is the driver for effective collaboration across the movement to deliver a central source of trusted product information that enables continuous process improvements.

SPINCO is the unit of MSF that was proposed and developed by the logistics and medical departments with the name ITC. The International Technical Coordination was officially recognised at International level in 1994 to maintain consistency in the choice of medical and non-medical articles between MSF sections in order to improve MSF interventions, while taking into account field realities. In 2006 ITC was integrated into MSF International.

The core role is coordinating the expression of the demand of articles (medical and non medical) and ensure it is properly translated for supply whose role is to fulfil that demand. For the last 25 years, SPINCO (former ITC) has been coordinating, producing and dispatching MSF catalogues within the movement which have been developed over all these years to be aligned with the operational needs in the field.

In 2016 UniData has been implemented, which is the unique central article database of MSF that contains all the products created in MSF, avoiding duplication, improving the articles description. Therefore, it provides visibility on the expression of the demand and helps streamlining supply chain processes. UniData details standard, non-standard and non-standard local products, with their descriptions, available for the field and shares article changes with the MSF movement.

SPINCO has been continuously implementing new tools and projects according to operational field priorities. Whilst the focus remains on making the product information available, by integrating UniData with systems and tools across MSF, UniData brings us up to date with the today’s way of working.

2. MISSION

The mission of SPINCO is fourfold:

Social Mission Focus

To contribute towards MSF’s social mission by enabling improvements to field operations through the provision of product information to all layers in the organisation. This enables product quality and visibility for better quality of care, enables assortment management, improves supply chain performance and increases overall interoperability whilst reducing duplications of effort.

Governance

To continuously improve the quality of product information by developing and enforcing information governance rules, definitions and processes. This is done in close cooperation with multiple stakeholders in the domains of Operations, Medical, Logistics and Supply.

Information management

To provide a single source of truth for the product information and ensure that it is available in real time throughout the MSF movement and is accessible together with supporting information via a centralised point.

Co-ordination & Expertise

To provide expertise through product knowledge, services and tools that enable technical integration between the SPINCO systems & tools that manage the information and the MSF systems & tools used in assortment management, supply chain management and other processes for which information managed in SPINCO systems is needed.

Essential for harmonizing supplies on the field, the standardization process consists in clearly defining the most suitable equipment and supplies for a given situation, according to the following criteria:

• observance of the policies defined by the MSF medical and logistic directors
• quality and efficiency within the framework of MSF programmes
• easy maintenance and supply of spare parts/consumables
• “international agreement”: validation by all MSF sections
• purchasable by at least one European Supply Centre (ESC)

Therefore, a standard article has gone through a standardization process, supervised by SPINCO and is the best choice for field use.

1. OPEN / CLOSED ARTICLES

Normally, articles are OPEN => “open articles” refer to a GENERIC PRODUCT, which corresponds to a set of technical specifications fulfilling a given function.

This means that all products with the technical specifications as described in the technical sheet are liable to be purchased regardless of their brand. Each MSF section may choose the product to be supplied as long as the required technical specifications are met.

E.g.: Several manufacturers make an external hard disk which meets the technical specifications of the article

EXTERNAL DRIVE, 320 Gb (ADAPMEMOEG3I)

Occasionally , some articles are CLOSED => “closed articles” refer to a SPECIFIC PRODUCT of a certain model and brand.

This means that the article is a particular model of a particular brand, and all MSF centres must supply exactly the same model of the same brand. Closed articles have been selected due to quality and/or safety reasons by international working groups, including technicians of different sections. They are mainly (electrical) apparatuses where maintenance and supply of spare-parts, accessories and consumables are mandatory, and adapted to specific MSF conditions (dust, heat etc.).

E.g.: The article “CONCENTRATOR O2 (DeVilbiss 525KS)” refers only to the 525KS model manufactured by DeVilbiss.

2. KITS AND MODULES

Although every medical response should be specifically planned based on information provided by the exploratory mission and reliable data, a kit containing essential items is nonetheless useful for an emergency. Intended for emergency contexts, the kits are ready to be delivered within a very short timeframe.

A module is a set of articles which is either a part of a kit or the optional complement to a kit.

A code allows ordering an article without any ambiguity on what is requested and helps to streamline the supply chain. MSF has created an international codification based on the article’s English label, and is significant so that codes itself “tells” what is being ordered.

With the central masterdata system, UniData, both types of articles, standard and non-standard are codified with the following set of codification rules. An MSF code is composed of min 11 and max 13 alphanumerical characters and structured in 4 subdivisions.

In the order tools, the code of the article is followed by the attribute indicating the standardization level.

• STD = standard article ( = validated by the 5 operational centres = OC’s)
• NST = non-standard article (= not validated by the 5 OC’s but used by one or few operational centres)
• NSL = non-standard local article ( = validated by one or few OC’s and purchased locally due to country constraints).

The MSF catalogues include only STD articles.

1. THE GROUP SUBDIVISION

The GROUP is defined by 1 character which identifies a functional category. Some groups are exclusively medical and others exclusively logistic, while group K (kits) contains both categories.

9 groups have been defined:

2. THE FAMILY SUBDIVISION

The FAMILY is defined by 3 characters which identify a speciality within a group. A family is either exclusively medical, exclusively logistical or exclusively library, except the leaflets family (LEAF) which is both: medical and logistical.

Medical families

Logistical families

Field Library families

3. THE ROOT SUBDIVISION

The ROOT is defined by 4 characters and is built from the article’s English label or description.

E.g.: CLOXACILLIN, 250 mg, caps => CLOX

A same root can belong to several families:

E.g.: CLOXACILLIN, 250 mg, caps => DORA CLOX

CLOXACILLIN, 500 mg, powder, vial => DINJ CLOX

NB: When an article’s label starts with the letter “Z”, the first character of its root will be “Y” to prevent any confusion with the “local code”.

Electro-mechanical equipment and their accessories, consumables and spare-parts are identified with a root of 3 letters followed by a letter E for equipment, A for accessory, C for consumable, S for spare-part and T for test/control.

See introduction on Electro mechanical medical devices in Medical Catalogue Volume 3

4. THE SPECIFICATION SUBDIVISION

The SPECIFICATION is defined by 3 to 5 characters and allows the differentiation of two similar articles. These specifications are often significant and follow the rules set-up for that specific root.

For some groups of articles MSF chooses to work with a manufacturer (supplier) code instead of setting up an MSF code when it fits the following criteria

• technical complexity of the assortment
• clear codification of maximum 16 characters set up by the manufacturer with a good documentation reference, that can easily be consulted (catalogue or online)
• many articles concerning the same purpose or main article

On logistical side this is the case for articles such as Toyota spare parts.

On medical side this it the case for articles used for internal fixation: Stryker system and Nail of Sign.

These specific codes, called free codes, are built up with an MSF group and family followed by the manufacturer’s code which could be up to 16 characters long.

Example:

CORTICAL SCREW, self tapping, full thread, Ø4.5 x 24 mm (STRY340624);

V-BELT fan and alternator, PZ-HZJ78/79, pair (YTOY90916-02452).

The central masterdata system, UniData is implemented with some new codification rules.

The diverse code or “Z-code”, created by the OC’s (Operational Centers) and ESC’s (European Supply Centers) disappeared and are replaced by the code structure of a standard article. It will still be possible to make the difference between a standard, a non-standard code and a non-standard local code with another attribute directly linked to the code.

• STD = standard article ( = validated by the 5 OC’s)
• NST = non-standard article ( = not validated by the 5 OC’s but used by one or few operational centres)
• NSL = non-standard local article ( = validated by one or few operational centres and purchased locally due to country constraints)

A DIVERSE CODE (Z-code) was used in the past for the creation of LOCAL codes. It has a similar structure as the standard codes that allow classifying the referred article according to GROUP and FAMILY (as for a standard article), while clearly indicating who created it:

Places of issue for diverse codes:

• KE MSF in Nairobi
• SL MSF in Sierra Leone...

There are no LOCAL CODES in the catalogues, but they may appear in order tools.

The local codes are nowadays integrated in UniData following the same codification rules as the standard and non-standard codes (regular codes). The diverse codes (Z-codes) are progressively disappearing.

Everytime a respirator is put on, PERFORM A SEAL CHECK

Stand in front of a mirror and fully open the respirator

STEP 1: Cup the respirator in your hand with the nosepiece at your fingertips

STEP 2: Position the respirator under your chin with the nosepiece up in order to cover the chin, the mouth and the nose

STEP 3: Pull the top strap over your head resting it high at the back of your head. Pull the bottom strap over your head and position it around the neck below the ears

STEP 4: Mould the nosepiece (using two fingers of each hand), to the shape of your nose

STEP 5: Cover the respirator with both hands, being careful not to disturb the position of the respirator

• Inhale deeply in order to create an air vacuum: if the seal is good, the respirator will cling to your face
• Exhale sharply: if the seal is good, the respirator will slightly expand
• Inhale and exhale several times: no leakage of air between the face and the respirator may be detected

If problems are met (the respirator does not collapse neither expand or if air leak is detected), adjust the respirator and retest the seal. In case the problems persist, replace the respirator and/or try another model or size. Once the respirator is correctly fitted, don't manipulate it any longer.

DEFINIITION

Shelf life is the term or period during which a commodity remains suitable for the intended use. ”Shelf life” refers to the durability under specified storage and transport conditions defined by the manufacturer until the immediate packaging is opened for the first time.

An expiry date (“use-by” date) is the termination of shelf life, after which a percentage of the commodity, e.g., medical devices, may no longer function as intended.

To determine if a particular device requires an expiry date, there are a number of different parameters that must be considered. The device must be analyzed to determine if

• it is susceptible to degradation that would lead to functional failure
• the level of risk that the failure would resent

For some devices, e.g., tongue depressors, it is not reasonable to assign a shelf life because of the small likelihood of time-dependent product degradation and the lack of serious consequences if it did fail to perform as designed. For devices intended to treat life-threatening conditions, the failure rate should approach zero within the labeled shelf life.

SHELF LIFE TESTING OF DEVICES AND PACKAGING

For CE marking of Medical Devices, as a part of the Technical File, manufacturers need to define the shelf life of their device, which is also mandatory as a component of Risk assessment. Shelf life refers to the durability under specified storage and transport conditions defined by the manufacturer until the immediate packaging is opened for the first time.

Essential requirements are set forth in the MDR and in the ISO 13485

Based on the type of the device, chemical, physical, microbiological, toxicological, technological as well as packaging aspects have to be considered while determining the shelf life of a product. This also applies to the storage and climatic conditions: compliance to the climate zones of the target markets have to be taken into consideration also. In case of Active medical devices the lifetime of the device is calculated by a compiled calculation of all the critical components of the device.

Testing should be conducted on a minimum of three to four batches to eliminate the variability related to the raw material and production processes. Also the intervals between tests conducted need to be risk based and has to be distributed throughout the shelf life of the product.

• Product testing: ease of assembly, simulated use and ease of use, dose accuracy, tamper evidence, visual inspections, dimensions, connection compatibility
• Packaging testing: ISO 11607 package validation, integrity, seal strength, sterile barrier system, transport simulation

The shelf life can be determined by either a real time or an accelerated ageing test where Arrhenius Law is applied in a simulated environment.

EXPIRY OF MD WITH LIMITED SHELF LIFE

Sterile medical devices (ex: injection supplies)

A sterile item with a passed expiry date cannot be considered as sterile anymore and must be eliminated. If the expiry date only mentions the month and the year, it is the end of the month which has to be considered the use-by date. The evolution with time of the constituent materials of medical/surgical equipment can only be determined by the manufacturer who knows exactly its composition.

The period of validity only applies if transport and storage are carried out under good conditions (protected from heat, humidity and light) and for items of which the sterile primary packaging is intact. The item cannot be considered sterile any more if the primary packaging is deteriorated (cracks, moldy).

Non sterile medical devices (ex: adhesive tape)

An item with a passed expiry date does no longer have the properties required for its use and should not be used. The period of validity only applies if transport and storage are carried out under good conditions (protected from heat, humidity and light) and for items of which the primary packaging is intact.

TERMS & DEFINITIONS

State of sterility

The concept sterile is referred to as a state completely free of any viable microorganisms, and sterilisation is defined as the process which will destroy all viable microorganisms.

“Sterile” is an absolute term, but the assurance that any given item is sterile, i.e. free from viable microorganisms, is a probability function. The Sterility Assurance Level (SAL) is defined as the probability of a medical device being non-sterile after exposure to a validated sterilization process. The SAL defined by the norm EN 556 is 10-6, i.e. the probability of a viable organism being present after sterilization must be less than 1 per 1 million.

Sterilization batch

Items are grouped in sterilization batches (= packaging units sterilized during the same operation) to guarantee their traceability and allow the post-marketing monitoring.

Sterilization controls

These include the sterilization control (tests on the process) and the sterility control (tests on the finished product).

STANDARDS USED IN STERILIZATION OF MD

ISO 13485

Medical devices -- Quality management systems -- Requirements for regulatory purposes, Parts related to sterilization of medical devices:

• Sterile Medical Device Clause 3.20 states that sterility requirements of each medical device can be subject to applicable regulatory requirements.
• Contamination control (Clause 6.4.2) addresses the prevention of contamination after the devices are sterilized.
• Particular requirements for sterile medical devices (Clause 7.5.5) sets two direct requirements:
• Records of process parameters of sterilization of each batch
• Traceability of all batches
• Requirements for validation of processes for sterilization and sterile barrier systems (Clause 7.5.7)

EN 556-1

Sterilization of medical devices - Requirements for medical devices to be designated “STERILE” - Part 1: Requirements for terminally sterilized medical devices (+ AC:2006)

ISO/Technical Committee 198 : Sterilization of health care products

Scope: Standardization of processes and equipment for sterilization of health care products.

• ISO 11135: Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices
• ISO 11137 set: Sterilization of health care products -- Radiation
• ISO 11138 set: Sterilization of health care products -- Biological indicators
• ISO 14161: Sterilization of health care products -- Biological indicators -- Guidance for the selection, use and interpretation of results
• ISO 11139: Sterilization of health care products -- Vocabulary of terms used in sterilization and related equipment and process standards
• ISO 11140 set: Sterilization of health care products -- Chemical indicators
• ISO 15882: Sterilization of health care products -- Chemical indicators -- Guidance for selection, use and interpretation of results
• ISO 11607 set: Packaging for terminally sterilized medical devices
• ISO 11737-1: Sterilization of health care products -- Microbiological methods
• ISO 13408 set: Aseptic processing of health care products
• ISO 14937: Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
• ISO 15883 set: Washer-disinfectors
• ISO 17664: Processing of health care products -- Information to be provided by the medical device manufacturer for the processing of medical devices
• ISO 17665 set: Sterilization of health care products -- Moist heat
• ISO 25424: Sterilization of health care products -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devices

MAIN MEDICAL STERILIZATION METHODS IN INDUSTRY

DISINFECTION AND STERILIZATION IN THE FIELD

Disinfection and sterilization of reusable medical devices are mandatory procedures to prevent nosocomial infections (infections acquired by the patients or the medical staff in a health care facility, also called hospital-acquired infections or health care-associated infections.

Disinfection, sterilization or single use MD according to the level of infection risk

(For detailed procedures, please refer to ‘Disinfection and sterilization protocols for MSF projects, 2010 – updated OCP version = 2013)

! SINGLE-USE EQUIPMENT MUST NEVER BE REUSED OR RE-STERILISED !

Steam sterilization

Steam sterilization is the only recommended method for sterilization of immersible thermo-resistant MD in health care facilities. It is a reliable, simple and not toxic procedure. It requires a steam autoclave, a source of energy (electricity, fuel, gas), water with a checked or controlled quality and a basic training. All these conditions must be fulfilled, including in emergency situations.
Protocol:

• pre-disinfection by immersion in a detergent-disinfectant solution (Anios®Clean type) for minimum 15 minutes
• cleaning-disinfection with a detergent-disinfectant solution (Anios®Clean type) for 15 minutes
• sterilization by steam autoclave

Important: The maximum shelf life recommended for medical devices wrapped in a double layer of sterilization paper (non-woven or crepe paper) is 2 weeks after sterilization.

High level disinfection

“High-level” disinfection concerns a very restricted number of medical devices, non-autoclavable, immersible and thermosensitive MD, likely to be reused. It consists in temporarily eliminating the vegetative forms of bacteria and viruses (but not bacterial spores) by immersion in a strong disinfectant solution.

Comment on boiling (not recommended)

Boiling for 20 minutes (+ 5 minutes / 1000 m altitude) in a recipient eliminates vegetative forms of bacteria and viruses, including hepatitis and HIV, but does not destroy bacterial spores. Boiling is not a recommended method and is only acceptable in situations where steam sterilization and “high” disinfection are impossible (e.g. traditional birth attendants in remote area).

Procedures according to the level of disinfection

Steps of steam sterilization

By “CLEAN WATER “ is meant FILTERED, non salt, low or non chlorinated water, as drinking water, tap water or rainwater if quality is controlled.

Manufacture

• 5.1.1 : Manufacturer (+ name and address)
• 5.1.2 : Authorized representative in the European Community / European Union (+ name and address)
• 5.1.8: Importer (+ name and address)
• 5.1.9: Distributor (+ name and address)
• 5.1.11: Country of manufacture (the CC in the symbol shall be replaced 2 or 3-letter country code)

Identification of product

• 5.1.5: Batch code = lot code = batch number
• 5.1.6: Catalogue number = reference number = reorder number = commercial product code
• 5.1.7: Serial number
• 5.1.10: Model number

User information

• 5.1.3: Date of manufacture
• 5.1.4 : Use-by date : the date after which the device is not to be used (after the end of the year, month or day shown)
• 5.2.8: Do not use if package is damaged and consult instructions for use
• 5.4.3: Consult instructions for use
• 5.4.4: Caution

Safe use

• 5.4.1: Biological risk
• 5.4.5: Contains or presence of natural rubber latex as material of construction within the medical device or the packaging of it.
• 5.4.10: Contains hazardous substance(s)
• 5.4.2: Do not re-use = medical device is intended for single use only = use only once
• 5.4.12: single patient multiple use: the medical device may be used multiple times on a single patient

Sterility

• 5.2.1: Sterile: indicates that a medical device has been subjected to a sterilization process.
• 5.2.2: Sterilized using aseptic processing techniques
• 5.2.3: Sterilized using ethylene oxide
• 5.2.4: Sterilized using irradiation
• 5.2.5: Sterilized using steam or dry heat
• 5.2.6: Do not resterilize (only to be used when there is also the sterile symbol)
• 5.2.7: Non-sterile (to be used only to distinguish between identical or similar medical devices sold in both sterile and non-sterile conditions)
• 5.2.12: double sterile barrier system

Storage conditions

• 5.3.1: Fragile, handle with care
• 5.3.2: Keep away from sunlight = keep away from heat
• 5.3.3: Protect from heat and radiation sources
• 5.3.4: Keep dry = keep away from rain
• 5.3.5: Lower temperature limit (+ temp limit adjacent to lower horizontal line)
• 5.3.6: Upper temperature limit (+ temp limit adjacent to upper horizontal line)
• 5.3.7: Temperature limit (+ temp limits adjacent to both horizontal lines)
• 5.3.8: Humidity limitation (+ limits adjacent to both horizontal lines)
• 5.3.9: Atmospheric pressure limitation + limits adjacent to both horizontal lines)

IVD-specific

• 5.5.1: In vitro diagnostic medical device
• 5.5.2: Control material intended to verify the performance of another medical device
• 5.5.3: Negative control
• 5.5.4: Positive control
• 5.5.5: Contains sufficient for “n” tests

Transfusion / infusion

5.6.2: Fluid path present (liquid or gas)

5.6.3: Non-pyrogenic

5.6.4: Drops per milliliter: the number of drops to be specified in the symbol

5.6.5: Liquid filter with pore size: the infusion or transfusion system of the medical device contains a filter of a particular nominal pore size (size indicated in the symbol)

5.6.6: One-way valve: the flow is only possible in one direction and cannot be reversed

General / other

• 5.7.7: Medical Device
• 5.7.9: Repackaging (+ name + address of unit responsible for repacking, if not by manufacturer)
• 5.7.10: Unique Device Identifier

1 Legal provisions

Biological samples are considered “dangerous substances” whose transport is subject to strict regulation based on the United Nations “Recommendations on the Transport of Dangerous Goods”.¹

The International Air Transport Association (IATA) has incorporated these recommendations into its “Dangerous Goods Regulations,” to which many airlines are subject, including express transporters like DHL. These regulations are updated annually.

International air transport regulations (IATA) are the most restrictive.
Whatever the type of transport – national or international, road, rail, maritime, or air – all MSF shipments of potentially infectious samples must comply with those regulations.

According to the “Recommendations on the Transport of Dangerous Goods”, all biological samples fall into the “6.2-Infectious Substances” risk class.

¹ UN Library, 2019. Recommendations on the Transport of Dangerous Goods: Model Regulations. https://doi.org/10.18356/7c03b465-en

2 Sample classification

Infectious substances are divided into three categories according to risk

Information regarding the danger category for each of the pathogens described in the MSF guideline 'Collection, storage and transport of samples from field to reference laboratory', chapter 2. A table of all Category A infectious substances – UN2814 can be found in Section 6.1.

A declaration is also required when using dry ice as a cooling agent, because it is a dangerous substance. The following must be added to the packages in question: UN1845 “Carbon dioxide, solid” (+ specific hazard label). The following must also appear on the Air Waybill (AWB): UN1845 “Carbon dioxide, solid”, the number of packages, and the net quantity of dry ice added per package. This must also appear on the Dangerous Goods Declaration, if it accompanies UN2814 infectious substances.

Every type of international transport has specific documents and conditions regarding:

• The packing instruction
• Marking and labelling
• Transport mode
• Administrative documentation

It is therefore necessary to:

• Assign the dangerous substance to be transported to one of the three categories (UN2814, UN3373, or exemptions). It is up to the medical staff to determine which categories the samples in question belong to.
• Know the recommended transport temperature: ambient temperature or cold chain (positive or negative).
• If there is any doubt or question, consult the laboratory advisor.

2.1 Special case of dried blood spot (DBS) shipments

According to the IATA, DBS shipments are exempt.²

The completely dry DBS should be placed in its own bag with desiccant, and the bag placed in an envelope and shipped by a rapid transporter with shipment tracking (e.g., DHL, UPS, or FedEx).

DBS samples shipped via transporter must meet the following criteria:

• Triple packaged, with two waterproof inner packagings (individual bags and then a zip-lock bag).
• A third (outer) packaging (envelope or cardboard box) measuring at least 10 x 10 cm.
• “Exempt Human Specimen” appears on the package (outer packaging) and on the Air Waybill.

The transporter may ask for documentation proving that the samples are exempt.³ Check with the laboratory advisor.

3 Biological substance, Category B - UN3373

3.1 Transport materials, transport temperature, and packing instruction

Regardless of transport temperature, the packaging must consist of the following three components:

• A primary receptacle
• A secondary* packaging, and
• A rigid outer packaging

* For liquid biological substances, enough absorbent material should be placed between the primary receptacle(s) and the secondary packaging to absorb the entire contents in case of leakage. Each primary sample should be individually wrapped so that there is no contact between samples.

The maximum volume of the primary receptacle is 1 litre, and the outer packaging should contain no more than 4 litres of dangerous liquid substances, e.g., blood or urine samples, or 4 kg of dangerous solid substances (e.g., swabs or Trans-Isolate). This weight or volume does not include ice packs or dry ice.

Note: depending on the quantity of dangerous substances to be shipped, check the maximum weight or volume for which the packaging was manufactured, which may be less than the quantities above.

The manufacturer will provide the product characteristics.

• Ambient temperature transport: IATA packing instruction 650. Two items available in the MSF catalogue:
• BOX, triple packaging, biological substance UN3373 +pouch [STSSUN62DS-] (Figure 6.1)
• BOX, triple packaging, biological substance UN3373+container [STSSUN62DS2]
• + POUCH, polyethylene, for transport of samples, 20 x 30 cm [ELABPOUP203]
• Cold chain transport between +2 and +8 °C: IATA packing instruction 650. Two items available in the MSF catalogue:
• BOX ISOTHERMAL, triple pack., biological subst. UN3373 +pouch [STSSUN62DSI] [Figure 6.2]
• BOITE ISOTHERME, triple emb, substance biologique UN3373 + récipient [STSSUN62DSI2]

[Figure 1 - Shipping material UN3373]

[Figure 2 - Shipping material UN3373] Ambient temperature Cold chain

The temperature is controlled by four ice packs that are pre-frozen and placed between the secondary and outer packaging.

With four ice packs, the insulated box should keep the samples between +2 °C and +8 °C for 48 hours at an ambient temperature of +28 °C.

Additional materials available:

• CONTAINER, PROTECTION, transport of sample, plastic, Ø 30 mm [STSSCONP030P]
• CONTAINER, PROTECTION, transport of sample, plastic, Ø 44 mm [STSSCONP044P]
• CONTAINER, PROTECTION, transport of sample, plastic, Ø 130mm [STSSCONP130P]

3.2 Marking and labelling

The regulations on marking and labelling for ambient temperature transport and cold chain (+2 °C to +8 °C) transport are the same. Additional information and a hazard label are required on outer packaging containing dry ice (see Section 6.2).

The outer packaging should display the following information:

• The following pictograph, measuring at least 50 mm a side, with the text “Biological substance, Category B” in letters at least 6 mm high adjacent to the pictograph.

[Figure 3 - Pictograph UN3373]

• The name and physical address of the recipient must be entered in the spaces provided (no post office boxes but any details that might facilitate direct delivery).
• The name and physical address of the sender should be entered in the spaces provided.
• The name and telephone number of someone in the field who can be contacted 24 hours a day should be entered in the spaces provided.
• Shipments to the Institut Pasteur laboratory in France must bear the Institute’s own shipping label (voir Section 6.5).

3.3 Transport modes

DHL: biological substances, Category B - UN3373 can be shipped via DHL or other transporters or airlines.

For cold chain shipments, the transporter must be informed so that the package is placed in a refrigerated cargo container, if available.

Notes:

• DHL can transport refrigerated packages but does not maintain the cold chain (i.e., it does not replenish ice packs or add dry ice for cold chain shipments). The sender is responsible for ensuring that the cold chain system used (ice packs or dry ice) is sufficient for the entire duration of shipment.
• Some transporters/forwarding agents do monitor the cold chain, replenish ice packs, or add dry ice (World Courrier, for example). It is the sender’s responsibility to enquire about the options ahead of time

​3.4 Administrative documents

These are the responsibility of the supply and logistics departments.

Shipments of Biological Substances, Category B – UN3373 do not require dangerous goods declarations (DGD), even when shipped with dry ice.

• A donation certificate with the recipient’s and sender’s addresses, the exact name of the suspected pathogen and the quantities being shipped (completed by the supply department (see Section 6.3).

• A “custom invoice” specifying the monetary value of the product (prepared by the supply or logistics department) with the recipient’s and sender’s addresses, the number of packages, detailed contents, and weight.
• A Material Transfer Agreement issued by the Ministry of Health or other competent authority in the country.
• For some countries, an import permit is required and should be furnished by the receiving laboratory.

A paper copy of these documents is given to the forwarding agent in the originating country. If there is a forwarding agent involved in the destination country as well, all the documents must be provided to him in electronic form (logistics/supply department responsibility).

• An anonymised packing list (without patient’s name) should be inserted between the secondary and tertiary packaging of the package in question
• A copy of the packing list and the package’s anticipated arrival date should be emailed to the receiving laboratory.

The forwarding agent: an essential service provider for all air shipments of infectious or biological substances (UN2814 and UN3373). If shipment with DHL, DHL takes the role of forwarding agent.

• Is commissioned by MSF.
• Is the intermediary between MSF and the airline at departure and between the airline and the receiving laboratory.
• When shipping via DHL, DHL manages the entire shipment (“door-to-door” service). If not shipping via DHL, a forwarding agent is needed at departure and a second forwarding agent may be needed to collect the package at arrival and facilitate its passage through customs.
• Completes the air waybill (AWB) (see Section 6.4) :
• The AWB should show “UN3373 Biological substance, category B” but not the name of the infectious agent. It should also include the number of packages.
• An accredited DHL account number must be used for UN3373 shipments. Contact the supply centre, laboratory advisor, or mission to get that account number.

When shipping via DHL, you must also notify the headquarters transport manager and forward the DHL tracking numbers (Air Waybill) (MSF-OCBA, MSF-OCG and MSF-OCP: MSF-Log focal point in Bordeaux; MSF-OCA: the transport officer at the APU and the mission laboratory advisor; MSF-OCB: laboratory advisor).

Other conditions may be required for cargo shipments. Contact the supply/logistics advisor and notify the medical department.

​4 Infectious substance, Category A - UN2814

4.1 Transport materials, transport temperature, and packing instruction

Regardless of transport temperature, the packaging must consist of the following three
components:

• A watertight, leak-proof primary receptacle(s)
• A watertight, leak-proof secondary packaging*
• A rigid outer packaging

* For liquid infectious substances, enough absorbent material should be placed between the primary receptacle(s) and the secondary packaging to absorb the entire contents in case of leakage. Each primary sample should be individually wrapped so that there is no contact between the sampless.

Maximum allowable volume per package:

• 50 mL or 50 g for passenger plane transport,
• 4 litres or 4 kg for cargo plane transport

This weight or volume does not include ice packs or dry ice.

• Ambient temperature, IATA packing instruction 620
• One item available in the MSF catalogue:
• BOX, triple packaging, infectious substance UN2814 [STSSUN62IS-]

[Figure 4 - Shipping material UN2814 - Ambient temperature]

[Figure 5 - Triple packaging box UN2814 - Ambient temperature]

• Cold chain transport between +2 and + 8 °C, IATA packing instruction 620
• The temperature is controlled by four ice packs that are pre-frozen and placed between the secondary and outer packaging.
• One item available in the MSF catalogue:
• BOX ISOTHERMAL, triple pack., infectious substance UN2814 [STSSUN62ISI]

[Figure 6 - Shipping material UN2814 - Cold chain]

[Figure 7 - Triple packaging box UN2814 - Cold chain]

Insulated box that keeps the samples between +2 °C and +8 °C for 48 hours (at an ambient temperature of +28 °C).
Additional materials available:

• CONTAINER, PROTECTION, transport of sample, plastic, Ø 30 mm [STSSCONP030P]
• CONTAINER, PROTECTION, transport of sample, plastic, Ø 44 mm [STSSCONP044P]
• CONTAINER, PROTECTION, transport of sample, plastic, Ø 130mm [STSSCONP130P]
• POUCH, polyethylene, for transport of samples, 20 x 30 cm [ELABPOUP203]

4.2 Marking and labelling

The regulations on marking and labelling for ambient temperature transport and cold chain (2 °C to +8 °C) transport are the same. Additional information and a hazard label are required on outer packaging containing dry ice (see Section 2).

The outer packaging should display the following information:

• The following pictograph (infectious substance symbol) (pre-printed on MSF materials) with UN2814 “Infectious substance, affecting humans”.

[Figure 8 - Pictograph infectious substance]

• The name and physical address of the recipient must be entered in the spaces provided (no post office boxes but provide any details that might facilitate direct delivery).
• The name and physical address of the sender should be entered in the spaces provided.
• The name and telephone number of someone in the field who can be contacted 24 hours a day should be entered in the spaces provided.
• Shipments to the Institut Pasteur lab in France must bear the Institut’s own shipping label (see Section 6.6.5).

4.3 Transport modes

• Infectious substances, Category A – UN2814 can be transported by an airline or possibly other transporters accredited by the IATA for UN2814 shipments (enquire locally). They cannot be transported by DHL.
• For cold chain shipments, the transporter must be informed so that the package is placed in a refrigerated cargo container, if available.
• Transporters can transport refrigerated packages, but not all of them maintain the cold chain (i.e., they do not replenish ice packs or add dry ice for cold chain shipments). The sender is responsible for ensuring that the cold chain system used (ice packs or dry ice) is sufficient for the entire duration of shipment.

4.4 Administrative documents

These are the responsibility of the supply and logistics departments.

• A dangerous goods declaration (DGD): must include “Infectious substance, affecting humans (+ scientific name of the substance, if known, in parentheses)” or “Infectious substance, affecting humans (+ suspected Category A infectious substance, in brackets” (for example: “Infectious substance, affecting humans (Ebola virus)” or “Infectious substance, affecting human (suspected Category A infectious substance)”) + the net quantity. (see example, Section 6.2).
  Note: the DGD must be completed and signed by an IATA-accredited person. If this is not the case for MSF personnel or the local forwarding agent, contact the supply/logistics department and your laboratory advisor to get a list of accredited people within the departments.
• A donation certificate with the address of the sender and the recipient, the exact name of the suspected pathogen, and the quantities contained, completed by the supply department (see, Section 6.3).
• A custom invoice (with the monetary value of the product) prepared by the supply department or logistics coordinator, with the sender’s and recipient’s addresses, the number of packages, their contents, and their weight.
• A Material Transfer Agreement (MTA) issued by the Ministry of Health or other competent authority of the country.
• For some countries, an import permit is required in the recipient’s country; this will have to be furnished by the receiving laboratory.

A paper copy of these documents is given to the forwarding agent in the originating country. If there is a forwarding agent involved in the destination country as well, all of the documents must be provided to him in electronic form (logistics/supply department responsibility).

• An anonymised packing list (without patient’s name) should be inserted between the secondary and tertiary packaging of the package in question.
  A copy of the packing list and the package’s anticipated arrival date should be emailed to the receiving laboratory.

The forwarding agent: an essential service provider for all air shipments of infectious or biological substances (UN2814 or UN3373).

• Is commissioned by MSF.
• Is the intermediary between MSF and the airline and/or between the airline and the receiving laboratory.
• In some cases, a second forwarding agent may be needed to collect the package on arrival and facilitate its passage through customs.
• Completes and signs the DGD if he has been accredited by the IATA for less than two years.
• Completes the AWB (Air Waybill) (see Section 6.4):
• The “handling information” box on the AWB must state “dangerous goods as per associated DGD”.
• The AWB should include “UN2814 Infectious substance, affecting humans”, but not the name of the infectious agent.

Other conditions may be required for cargo shipments. Contact the supply/logistics advisor and notify the medical department.

5 Cold chain preparation

The insulated boxes available in the catalogue will keep the temperature between +2 °C and +8 °C for 2 days at an ambient temperature of 28 °C. It has not been tested at higher ambient temperatures.

5.1 Shipping at +2 °C to +8 °C with 0.6-litre ice packs

The procedure for samples that have to be sent at +2 °C to +8 °C using ice packs is as follows:

• Prepare an insulated triple-packaging box.
• Prepare the four ice packs:
• Remove them from the freezer and leave them in a +20°C location, protected from the sun.
• After 15 minutes, check the amount of liquid in the ice packs. To ensure that the ice packs are at the right temperature, they should have 5 cm of water visible in the bottom when held vertically. When the ice packs are shaken, the sound of water can be heard.
  ! If there is less than 5 cm of water or no water at all, the packs are too cold, and the samples might freeze early in transport !
  ! If there is more than 5 cm of water, the packs are too warm, and the temperature might get too high during transport !
• If the ice packs are not at the correct temperature after 15 minutes, leave them for another 15 minutes, protected from sunlight, and then check again.
• Once all four ice packs are at the correct temperature, place them in the insulated box.
• Put the samples, in their packaging, into the box.
• Close the insulated box.

6. Documentation

6.1 IATA : Category A - UN2814

Indicative examples of infectious substances included in Category A in any form unless otherwiseindicated

Adapted from Guidance on regulations for the transport of infectious substances 2021-2022. Geneva: World Health Organization; 2021. Licence: CCBY-NC-SA3.0IG

6.2 Sample dangerous goods declaration (DGD)

6.3 Sample donation certificate

6.4 Sample Air Waybill (AWB)

6.5 Institut Pasteur shipping label

Available at the following address:

https://www.pasteur.fr/fr/file/3157/download?token=Evu6jsP5

Regardless of the mode of transport, fill out and affix a label as above to the outer packaging of all shipments destined for the Institut Pasteur's National Reference Centers.

Sender:

• Name
• Hospital/Laboratory/Unit
• Address
• Postal code
• City
• Country
• Phone number
• Fax number

Storage conditions: choose one

• Ambient temperature
• + 4 °C
• -20 °C

Recipient:

• Institut Pasteur
• National reference laboratory of _______________________________
• For the attention of _________________________________________
• Address: already added
  

References

1. Guidance on regulation for the transport of infectious substances 2021-2022/WHO
https://apps.who.int/iris/handle/10665/339825

2. Exempt Human/Animal specimens shipping guidelines. Retrieved from :
https://www.cancertrials.ie/wp-content/uploads/2018/05/DHL_Exempt-Human-Animal-Specimen-Customer-2015.pdf

3. IATA document. Dangerous Goods Regulations (DGR). 62nd Edition. 2021. Retrieved from

QUALITY SHEET

Caution!

This document as well as the technical sheets of non specialized food products are intended to provide information on what we consider to be ideal with regard to products, packaging, and purchase conditions. Depending on the amount purchased, the frequency of purchase and the supplier, you should come as close as possible to this ideal by demanding the maximum number of guarantees (certificates,monitoring agency services, sampling,analysis, phytosanitary treatments, etc.).

• If the project’s basic foodstuffs do not require storage (e.g., small quantities bought daily on the local market), it will be difficult for you to follow the quality sheets recommendations. In this case, we recommend that:
• you buy in this way only those foodstuffs that warrant it, that is, which don’t lend themselves to storage (fresh produce, meat, etc.)
• you choose the same quality you would for consumption by MSF staff (to avoid dubious, inexpensive products)
• On the other hand, once food stocks are organized, each sheet should be read and followed. The larger the volumes, the more closely the recommendations should be followed. If some of them are hard to follow, discuss your alternatives with your coordination team/ headquarters, and come to a joint decision on a purchasing strategy. We recommend prioritizing quality guarantees over purchase location (local supermarket vs.capital, for example). Get as close as possible to the product’s source, and avoid intermediaries.

To sum up

• product that is hard to store: purchase locally, choosing products as if you are buying for the MSF team
• storable product: buy from a supplier who can provide quality guarantees

SPECIFICATIONS

MSF specifications and national specifications

MSF specifications have been written for each product. They are based on the codex alimentarius

The implementation of the recommendations of the codex alimentarius vary upon countries. We recommend that you consult the authorities to know the local specifications before purchase

Importations of foodstuffs are always subject to prior authorization by national authorities.

Consider the potential impact on local, national or regional market availability and prices before purchasing large quantities of basic foodstuffs.

Packaging and labelling

2% empty bags should be added to the shipment without additional charges.

Standard labelling

• Supplier initials/year/order no./section initials/ program code
• Médecins Sans Frontières
• Product
• Net Weight in kg
• Crop year
• Might be added the note: "Humanitarian donation".

PRECAUTIONS FOR PURCHASE

• In case of local or sub-regional availability of products outside of MSF standards, we recommend contacting headquarters for approval prior to purchase
• All products should be clearly labelled as being wholesome, sound, of market quality, and fit for human consumption. Getting a certificate of origin is a plus for guaranteeing the traceability of the product. The Cartagena Protocol requires producers/exporters to indicate whether their products do or do not contain GMOs (Genetically Modified Organisms).

Local purchases and inspection company

• Use and fill the appropriate "Contract for local purchase" (1 per product) ref. NSFOPURC++.
• In case of purchase of big quantity, make an inspection company (SGS, Cotecna, Véritas, FAIDEX, etc.) perform an inspection before loading. Use and fill the appropriate "Inspection contract" (1 per product) ref. NSFOINSP++.

Transport

• Check the transport modes used before shipping (cleanliness, protection, etc)
• Check the contract of carriage: the carrier must promise to take responsibility for any deterioration of goods during shipping (dirty trucks that previously transported hydrocarbons or other products incompatible with foodstuffs, trucks not covered despite the risk of rain, etc

Receiving

• Check the goods (for quantity/quality) upon receipt. Use and fill the "check list for the control upon receipt": NSFOCRECOOE (English), NSFOCRECOOF (French).

STORAGE AND MAIN RISKS FOR DETERIORATION

Storage

Follow the procedure QA-NFOS-SOP2 "Storage and stock management of food".

• Always store on pallets or groups of pallets
• Food products must always be separated from other products
• FEFO (first expired first out) inventory management
• Under humid tropical conditions, most insects can multiply by a factor of 50 in six weeks. Limit storage time is therefore a way to minimize insect infestation.

Humidity

• The relative humidity indicates the amount of water vapour in the air. It is expressed as a percentage and depends primarily on the precipitation pattern and atmospheric pressure (which increases with temperature).
• It is essential that stocks be kept at the lowest possible temperature and humidity (air humidity < 70%).
• An increase in the product’s moisture content due to high ambient air humidity promotes the growth of fungi which secrete toxins.
• The ability of microorganisms to multiply in foodstuffs increases in the presence of free moisture.

Insects, rodents and birds (pest control)

• Temperatures between 10 and 45ºC are most favourable to completion of their reproductive cycle.
• Rodents (rats and mice) represent an important risk factor for foodstuffs, packagings, buildings and staff.
• Prevention is the key word, it is necessary to treat in case of infestation.

Treatment

• It is essential to take action at the first sign of infestation in order to minimize reproduction of insects and damage to the foodstuffs. Follow the procedure MSF-NFO-SOP3.1: "Pest control".
• Fumigation is the main method of treating staple foods. Caution, phytosanitary treatments may only be performed by authorized organizations to prevent excessive quantity of residual pesticides. Safety conditions must therefore be met before any operation of fumigation, and only national organizations authorized and trained to handle such substances can perform fumigation.
• The decision to distribute mildly infested foodstuffs (1 to 2 living insects per kg of product) will depend upon the circumstances. Such a decision is acceptable if the product is consumed quickly. Higher infestation levels are acceptable for distributions if the product is intended to be ground prior to consumption.

Bibliography

Food logistics. Practical guide intended for logisticians and medical personnel involved in managing food products in the field (L046FOOM01E-P).

Specialised food products

Unlike basic food products (NFOO family) such as cereals (e.g., millet, sorghum) or legumes (e.g., beans), specialised food products‌ (NFOS family) are specifically formulated to meet the needs of malnourished people in crisis situation.

These products are enriched with proteins, minerals, and vitamins to match patients' nutritional requirements, taking into account factors such as age, severity of malnutrition, associated pathologies, and local dietary practices.

A comprehensive strategy to respond to a nutritional crisis can only be defined after an assessment of the nutritional situation, with clear intervention objectives and well-defined target populations. The response may be general or targeted, and may include general distribution, blanket feeding, supplementary feeding programmes, or therapeutic feeding programmes.

THE DIFFERENT TYPES OF SPECIALISED FOOD PRODUCTS

Specialised foods are designed to meet specific nutritional needs and can be grouped into several categories:

Therapeutic milks (F75 and F100)

Used in the treatment of Severe Acute Malnutrition (SAM):

• F75: used during the initial phase
• F100: used during the rehabilitation phase

RUTF - Ready-to-Use Therapeutic Food

Used in the rehabilitation phase of Severe Acute Malnutrition (SAM) treatment. Not suitable for the initial phase due to iron content.

• Examples: Plumpy’nut, eeZeepaste, Valid Nutrition, Insta paste, BP100

Caution: RUTF should not be used in children under 6 months of age.

RUSF - Ready-to-Use Supplementary Food

Used in the treatment of Moderate Acute Malnutrition (MAM) and as nutritional support in emergency contexts or to prevent malnutrition in nutritional programs.

• Examples: Plumpy'Sup, eeZeRUSF

Note: RUSF are sometimes referred to as LNS LQ (Large Quantity)

LNS - Lipid-based Nutrient Supplements

LNS MQ (Medium Quantity)

Ready-to-use product used to prevent Moderate Acute Malnutrition (MAM) in children aged 6 to 36 months. When consumed as a supplement to the regular diet, it balances the daily intake of micronutrients.

• Examples: Plumpy doz, eeZee50

LNS SQ (Small Quantity)

Ready-to-use product used to prevent malnutrition and nutritional support in emergencies.

• Examples: Nuttributter, eeZee20

Micronutrients Supplements (fortified paste with vitamins and minerals)

Used to correct dietary deficiencies, especially where diets lack of animal-based products.

• Examples: QBmix

Emergency Food Rations

Compressed biscuits used as nutritional substitutes or food supplements during the early phase of an emergency, before general ration distribution.

• Examples: BP5, NRG5

Infant Formulas (infant milks) and Breast-Milk Fortifiers

Used as breast milk substitutes or to enhance breast milk, when needed for infants with special nutritional requirements.

FSMP - Food for Special Medical Purposes

Tailored for patients with specific medical conditions (e.g., VHF, burns, HIV) and used under medical supervision. Can vary by:

• Age group: adults or children
• Caloric content: isocaloric or hypercaloric
• Protein content: normoprotein or hyperprotein
• Composition: semi-elemental, with or without fibres
• Forms: powder (for reconstitution), ready-to-use drinks, or ready-to-use bags for enteral (tube) nutrition (ready to hang).

Powders typically have a longer shelf-life (24 months), are more cost-effective than ready-to-use products, and simplify stock management and orders (less product references).

Contact your nutrition advisor before ordering FSMPs can serve as a sole food source or meal supplement (e.g., for VHF/Ebola patients unable to follow a normal diet or with severe anorexia).

Super Cereals (Pre-cooked Fortified Flours)

Used in:

• general distributions (WFP)
• family ration distributions
• supplementary and blanket feeding programs

Made from corn flour (CSB+) or wheat flour (WSB+) and soya cooked by extrusion or micronization, fortified with minerals and vitamins.

• Examples: Unimix (MSF-UNICEF-UNHCR), CSB/CSB+ (WFP), WSB (WFP).

Super Cereal plus (+) are newer versions containing milk, better adapted for children's nutritional needs.

• Examples: CSB++

PURCHASE / ACCEPTANCE OF DONATION OF SPECIALISED FOOD PRODUCTS

It is essential to manage stocks of specialised food products by batch and by shelf life. A batch is defined as a quantity produced under homogeneous conditions, although the exact definition may vary depending on the supplier's internal organisation.

Product quality depends on every stage of the supply chain:

• supply of raw materials, manufacturing, packaging, and storage at the supplier's premises
• transport
• storage
• distribution
• cooking (if applicable)
• consumption

Any issue or negligence at any of these stages can compromise the final product's quality. Therefore, strict adherence to the recommended procedures at each stage is essential.

All suppliers of specialised food products must undergo a rigorous validation process to ensure their products meet high-quality standards. Only validated suppliers should be used for procurement.

Local purchases are only permitted from validated suppliers. A list of validated suppliers is available from section pharmacists and nutrition referents.

All donations of specialised food products must be accompanied by a delivery note (waybill) specifying all batch numbers and best-before dates. Upon recept, carry out an inspection and a quality (organoleptic) assessment for each donation (see procedure below).

Documentation

Each shipment of specialised food products may include various certificates, which can be requested from the field.

These certificates may include: a health certificate, a certificate of analysis (mandatory for any reception), a certificate of origin, a certificate of conformity, a GMO/non-GMO certificate, etc.

SUPPLY AND STOCK MANAGEMENT

Specialised food products must be stored at temperatures below 30ºC to prevent quality issues and deterioration.

For detailed guidance, refer to procedure Storage and stock management of specialised food.

If storage conditions in the field exceed or have exceeded 30°C, it is recommended to have the product analysed by a laboratory to assess its integrity, particularly vitamin content, as vitamins are the most fragile components, and to determine a new shelf life. (see the sampling paragraph below).

Quality Control Procedures

Control at Reception

Complete the "Check list for control upon receipt": NSFSCRECOSE (English), NSFSCRECOSF (French). These forms are also available on request from the section pharmacist or nutrition referent.

A certificate of analysis (one per batch number) must be provided by the supplier for each delivery.

Specific case - Super Cereals:

For Super Cereals, complete the specific checklist: NSFSQCONFFF (French) / NSFSQCONFFE (English).

Sampling (for analyse in laboratory)

When products have been stored at temperatures above 30ºC, samples must be sent to a laboratory to check the level of fortification, particularly vitamin content, which can decrease with heat. This analysis may lead to an adjustment of the product's shelf life.

If a quality issue is suspected, it may be necessary to send samples to a laboratory. In such cases, contact your section pharmacist or nutrition referent. You may be asked to complete the sampling report form, NSFSSAMPOSF (French) / NSFSSAMPOSE (English).

PETROLEUM HYDROCARBONS

In some cases the same name refers to different fuels in different languages, which can lead to confusion.

For example, in French, petrol is called "essence" and kerosene (lamp oil) is called "pétrole (lampant)".

The table below presents the names of the different hydrocarbons in English, French and Spanish, along with their uses.

OILS

Oils are defined by two characteristics: the viscosity index and the quality index.

Classification of engine oil viscosity

This classification follows the SAE norm, defined by the Society of Automotive Engineers. The viscosity indicates how treacly a liquid is. The viscosity of a liquid depends on its temperature: the viscosity reduces at higher temperatures.

• At high temperature: the viscosity should be sufficiently high to assure the protection of the motor and avoid a break in the oil film.
• At low temperature: the viscosity should be sufficiently low to allow the motor to start up easily.

The behaviour of an oil under these two temperatures is normalized by the SAE grade. The cold viscosity grade is determined at -18°C, while the warm grade is determined at 100°C.

Example: SAE 10W40

where 10W = winter grade (W for winter) where 40 = summer grade

Choosing the correct viscosity grade depending on the range of outside temperatures.

Remark Only multigrade engine oils should be used, which are usually of better quality than single-grade oils.

Classification of engine lubricant quality

The API norm of the American Petroleum Institute classifies oils depending on their quality and performance.

For engine oils this norm is presented by 2 letters:

The first letter indicates for which type of engine the oil is used:

• S - petrol engines (spark plug ignition)
• C - diesel engines ( compression ignition)

The second letter indicates the level of performance, increasing with its alphabetical range:

• SA to SN: for petrol engines. SN corresponds to the maximum quality. Note: SA to SE oils are not compatible anymore for vehicles produced after 1979.
• CA to CJ: for diesel engines. CJ corresponds to the maximum quality. Note: CA to CC oils are not compatible anymore for vehicles produced after 1990.

Most engine oils available on the market can be used both for petrol and diesel engines. Therefore you can find on the jar both norms: API SH/CF.

Summerizing the following example: you may use an engine oil with specifications SAE 10W40 API SH/CF for a Land Cruiser, taking into account the climatologic environment and the temperature range in country of operation.

Avoid mixing different brands of engine oil.

Classification of transmission oil viscosity

The principle is the same is with engine oil, however the scale is not the same for an engine oil or a transmission oil.

For example: SAE 80W90.

Classification of transmission oil quality

For transmission oil the API norm is as follows:

API GL-1, GL-2, GL-3, GL-4 and GL-5. GL stands for Gear Lubicant. Note: GL-1 to GL-3 are obsolete.

The oil GL-5 is generally used for the differential, while GL-4 could be used for gear boxes and transfer boxes. Refer to the user manual of the manufacturer in case the MSF standard maintenance logbook specific to your vehicle type is missing.

A differential with a limited slip requires a dedicated lubricant.

OIL CHARACTERISTICS

VISCOSITY

• Viscosity is the thickness of a liquid or its resistance to flow. Low-viscosity liquids are more fluid and flow more easily, while those with higher viscosity are thicker and flow more roughly.
• Temperature affects the viscosity of your oil. At low temperatures, it is important to use an oil with low viscosity to facilitate circulation in the crankcase. At high temperatures, the oil must have a higher viscosity so that it can form a film and reduce friction and heating. See figure above.
• Defined by SAE (Society of Automotive Engineers) Higher grade = thicker oil. Using an oil with the wrong grade can negatively affect the performance and the reliability of your equipment.
• Multigrade oils are recommended because they keep their properties at high and low temperatures.
• MSF standard is 15W40 for all cars ordered internationally. When purchasing locally, always follow the recommendations in the manufacturer's service booklet.

API (AMERICAN PETROLEUM INSTITUTE) CLASSIFICATION

There are multiple codes to classify motor oils (API, ACEA, etc.) Only the API

classification will be discussed here. It defines the engine protection

performance of oil using a 2-letter code:

• C# is for diesel engines; S# is for petrol engines. Some oils are made both for diesel and petrol engines.
• The second letter (#) characterizes oil performance. The further away the letter is in the alphabet, the more efficient the oil will be.
• If there is a number after the second letter (#), 2 or 4, this number indicates whether it is a 2-stroke (-2) or 4-stroke (-4) engine oil. Always use -4 oil for land cruiser.
• Current highest quality is CK and SN (as of the end of 2020), but it should not be used in the Land Cruiser because it contains synthetic oil. MSF recommends mineral oil.

Though higher performing oil is generally more expensive, it is recommended to

use the highest quality available that is suitable for your fuel (see below). In

most cases, this is CI-4 (15W40 CI-4 Mineral),DIESEL SULPHUR CONTENT.

Current environmental regulations in Europe and North America require very low

concentrations of Sulphur in diesel fuel, but higher concentrations are still found

in many countries where MSF works. Sulphur content in diesel fuel can impact

engine oil characteristics, so it is important to select the appropriate oil (see

following page).

Consult your fuel supplier for the Sulphur content of the fuel. If the information

is not available, please consult your technical referent.

Sulphur content is measured in parts per million (ppm) and percent (%):

5,000 ppm = 5,000 ÷ 1,000,000 = 0.005 = 0.5%

CARS

MSF has selected the following standard vehicles with a standard preparation by ESC:

5 véhicules 4x4:

• Toyota HZJ76 (hard top), 6 seats, diesel
• Toyota HZJ78 (hard top), 11 seats, diesel
• Toyota HZJ79 (pick-up), 3 seats, diesel
• Toyota HZJ79 double cabin, 6 seats, diesel
• Toyota Hilux double cabin, pick-up, diesel

The choice will depend on your needs, the presence of local dealers, the existing MSF fleet, etc.

City car

It is recommended to execute a market survey on national or regional level, in order to validate a city car for the concerned mission, taking into account the specifications you’re looking for, the presence of local dealers, the availability and quality of the proposed options, etc.

PURCHASE OF VEHICLES

The procurement of a vehicle, either new or second-hand should always be discussed with your technical department and approved by them.

There are 2 possibilities for purchasing:

Purchase via an MSF supply centre

Toyota has entered into an agreement to supply vehicles that meet MSF's specifications.

The choice for a standard vehicle, allows you to benefit from prearranged spare part kits and a defined standard preparation developed for each type of vehicle.

Contact your technical department to know more about to what extent the options vary from one operational centre to another.

It is also reassuring to be able to benefit from the technicians expertise on a well-known and approved model.

Finally, the management tools developed especially for these models are available, such as the logbook and a spare parts order tool.

Note

Sea freight can take anything from 15 days (at best) to 2 months, and could costs between € 2200,- to € 7000,- (whereas air freight costs between € 8000,- to € 15000,- or even more). These indicative prices for transport could fluctuate depending for example on the level of access and the stability of the location / country of destination.

Local purchase

Usually more expensive, but shorter wait for delivery, which can be a requirement in emergencies.

Make sure that spare parts are available locally. Do not buy imitations, but only genuine manufacturer's parts.

In case of local purchase of non-standard vehicles, the supply centres cannot guarantee the supply of spare parts.

TOYOTA SPARE PARTS

Missions must establish stocks of spare parts.

Principally, planned spare parts orders (per semester) should be send to your supply centre. It is useful to explore the local market, to investigate the availability and prices of spare parts at local distributors. Even if you are considering importing spare parts, it can be useful to make an arrangement with a local dealer in case of emergency.

Spare part orders

There are 2 types of spare part orders:

• stock orders (every 6 months)
• specific orders for parts which are not stocked (when required)

MSF has developed a small program in Microsoft Excel to help you manage your stock and place orders for Toyota spare parts (see technical department).

To order parts which are not included in the MSF list, see the Toyota spare parts catalogue on paper or digitally if available.

The following must appear on your order:

• complete code of the model (i.e. HZJ78L- RJMRS)
• chassis number (i.e. JTERB71J700059235)

In case of doubt concerning the suitability of a part, attach as much information as you have to your order, and ask your technical department for advice.

Toyota spare parts catalogue

The paper version of this catalogue is no longer produced, however there might still be a copy available in your mission, which is only useful if it covers the production date of the concerned vehicle. It is not easy to use; you should therefore read the introduction very carefully before consulting the main body of the catalogue.

As spare parts are constantly developing, the catalogue quickly becomes outdated.

The alternative is the electronic spare parts catalogue, as long as the installed version covers the specifics such as the production date of the concerned vehicle.

Caution

To define the exact reference of a spare part for a certain model sometimes requires a technical interpretation and knowledge on the options and / or assemblies possible, even when using the digital catalogue.

Consult your technical department in case of doubt or need.

MANAGING THE VEHICLE FLEET

Vehicles are essential to the running of a project and must therefore be properly managed.

See the existing MSF guidelines on the subject.

MOTORCYCLES

As a general rule, motorcycles are not recommended for use in MSF missions because of the danger they pose to the rider.

In some situations, motorcycles may nevertheless be a good choice: for example in rural areas, where there is little traffic, for short journeys at low cost, for EPI, etc.

In all cases, the choice of model should be made in collaboration with your technical department, in accordance with the following points:

• Avoid larger cylinders, as more powerful models encourage higher speeds.
• Choose a model which is well-known and has a good network of dealers in the country.
• The use of good quality helmet and personal protection equipment (elbow, knee, boots & gloves) is mandatory.

PURCHASE OF MOTORCYCLES VEHICLES

The procurement of a vehicle, either new or second-hand should always be discussed with your technical department and approved by them.

There are 2 possibilities for purchasing:

Purchase via MSF supply centre

The choice for a standard vehicle, as proposed by your operational centre, gives you the advantage of the technicians expertise on a well-known and approved model.

In this case the management tools developed especially for this model, are available, such as the logbook and a spare parts order tool.

Contact your technical department for more information.

Local purchase

Make sure that spare parts are available locally. Do not buy imitations, but only genuine manufacturer's parts.

In case of local purchase of non-standard motorcycles, the supply centres cannot guarantee the supply of spare parts.

MANAGING THE VEHICLE FLEET

Vehicles are essential to the running of a project and must therefore be properly managed.

See the existing MSF guidelines on the subject.

In case the order of an article has to be justified, one or more justification codes (P, M, E, F, A, S) appear on the top of the technical sheet in the catalogue, and in a separate column on the order list. These codes give the reasons why the order of that article has to be justified. A more detailed explanation can be found in the catalogue, under the heading “Article to be justified”.

The request for justification aims at ensuring the programs’ quality, preventing medical risks, and highlighting the existence of programs that the medical or logistics department needs to be aware of.

P PROGRAM

Article reserved for a specific program (e.g.: drugs used in TB programs) or for specific applications (e.g.: HIV testing equipment used for pre-transfusion screening in surgical programs).

M MEDICAL RISK

Article involving a potential medical risk if misused. Its use is reserved for duly trained staff having sufficient knowledge of the medical context which is concerned (e.g.: drugs used in the treatment of angina pectoris).

■ Particular case:

Drug implying a potential risk of abuse and which must be used and/or prescribed by duly trained staff, and safely managed. It may be subject to particular national or international controls (e.g.: narcotic and psychotropic drugs).

E EXPENSIVE

Expensive article of which the choice has to be justified in comparison with cheaper alternatives, considering the cost-effectiveness, the sustainability of the program and the severity of the situation (e.g.: surgical sets for external fixators).

F FOLLOW-UP OR MONITOR

Article introduced in the MSF standard list, for which additional information is necessary in terms of criteria for use, evaluation, quality, consumption, ease of use, follow up of side effects etc.

A ACKNOWLEDGE

Article that needs to be adapted to each situation after a technical evaluation (e.g.: bungalow containers of which the configuration is specific to each installation).

S SECOND CHOICE

Article must only be used if the first choice is not available or cannot be used in a specific context

Once the order of an article has been justified and agreed by the medical or logistics department for one project, there is no need to justify the following orders of the same article for the same project.

CAUTION: All orders of non-standard medical articles have to be justified

Frequently, for reasons related to stability taste, or solubility, the base form of a drug is administered in an modified form, such a salt or an ester. This modified form usually has a different molecular weight.

For example, caffeine citrate:

There are therefore two ways of expressing the active ingredient content of a medicine: either according to the salt contained in the formulation (e.g., 20 mg of caffeine citrate in this case) or according to the base equivalent responsible for the pharmacological activity of the medicine (e.g., 10 mg of caffeine base).

In English-speaking countries, the content is typically expressed as the salt, whereas in French-speaking countries, it is usually expressed as the base. Unfortunately, there is no international standard for this, which frequently leads to confusion between the two methods. As a result, it is not unusual for drugs labelled as bases to be used in protocols that express them as salts, and vice versa.

For salts in which the non-active part is relatively small compared with active part, such confusion often results in negligible errors. However, with small active molecules combined with heavy salts (such as phosphates, sulphates, carbonates, citrates, and fumarates), the non-active part can account for more than half of the molecular weight. In such case, confusions can lead to underdosing, resulting in ineffective treatment or a risk of resistance, or overdosing, which increases the risk of adverse effects. Examples of such products include caffeine citrate solution for injection and chloroquine phosphate tablets.

International Narcotics Control Board (INCB)

The International Narcotics Control Board (INCB) is an independent, quasi-judicial expert body established under the 1961 Single Convention on Narcotic Drugs through the merger of two bodies:

• the Permanent Central Narcotics Board, established by the 1925 International Opium Convention, and
• the Drug Supervisory Body, established by the 1931 Convention for Limiting the Manufacture and Regulating the Distribution of Narcotic Drugs.

The INCB consist of 13 members elected by the Economic and Social Council for a five-years term and eligible for re-election. Ten members are elected from a list of candidates nominated by governments, while the remaining three are elected from a list nominated by the World Health Organisation (WHO) based on their medical, pharmacological, or pharmaceutical expertise. INCB members serve in their personal capacity, independently and impartially, and not as representatives of their governments.

The production and distribution of controlled substances must be licensed and supervised. Governments are required to provide the INCB with estimates and statistical reports on the quantities of drug required, manufactured, and used, as well as quantities seized by police and customs authorities. Each year, the INCB publishes data on illicit trafficking of drugs under international control.

International Classification of Narcotic and Psychotropic drugs

Approximatively 250 substances are listed in the schedules annexed to the Single Convention on Narcotic Drugs (New York, 1961, amended in 1972), the Convention on Psychotropic Substances (Vienna, 1971), and the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, including precursor control (Vienna, 1988). The purpose of these lists is to regulate and restrict the use of these substances according to their therapeutic value, potential for abuse, associated health risks, and the need to prevent the diversion of precursor chemicals for the illicit manufacture of drugs.

Narcotic drugs

Narcotic drugs are classified and placed under international control by the 1961 United Nations Single Convention on Narcotic Drugs, as amended in 1972. The convention limits "exclusively to medical and scientific purposes the production, manufacture, export, import, distribution of, trade in, use and possession of drugs" (Article 4c).

The Yellow List contains the complete list of narcotic drugs under international control according to the 1961 Convention.

The Yellow List is available at: https://www.incb.org/incb/en/narcotic-drugs/Yellowlist/yellow-list.html

Narcotic drugs are classified into four schedules:

Psychotropic substances

Psychotropic substances are classified and placed under international control by the 1971 United Nations Convention on Psychotropic Substances. The purpose of this Convention is to limit the use of these substances to medical and scientific purposes (Articles 5 and 7).

The Green list contains the complete list of psychotropic substances under international control according to the 1971 Convention.

The Green List is available at: https://www.incb.org/incb/en/psychotropics/green-list.html

Psychotropic substances are classified into four schedules:

Precursors

Precursors are chemicals frequently used in the illicit manufacture of narcotic drugs and psychotropic substances. They are subject to international control under the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances.

The Red List contains the complete list of precursors under the 1988 Convention.

The Red List is available at: https://www.incb.org/incb/en/precursors/Red_Forms/red-list.html

Precursors are classified in two tables with the MSF attribute "DP" (Drug Precursor).

International Order of Narcotic and Psychotropic drugs

When exporting or importing narcotic or psychotropic drugs, the legislation of all countries involved must be respected.

In most cases, the exporter must present an import permit from the destination country in order to obtain an export permit for these substances.

When importing for re-export (ImpEx) through a third country (e.g. via Kenya for Somalia), the regulations of the transit country must also be followed, unless a transit regime is used.

In some countries, additional controls may apply if these products are classified as chemical weapons by the Office of National Security, beyond the oversight of the National Drug Regulatory Authority.

Importing country

Verify import regulations and custom clearance with the Ministry of Health, the National Medicines Regulatory Authorities (NMRA), and other relevant authorities.

Some countries prohibit the importation of narcotics by humanitarian agencies or allow it only only in exceptional situation, such as national supply chain disruptions.

Import permit for narcotic and psychotropic drugs

Import permits are usually issued by the Department of Narcotics of the Ministry of Health or by the NMRA.

An import permit should include at least:

• permit number
• date of issue
• expiry date of the permit (usually at least 3-4 months to allow time for importation; extensions may be possible in some countries).
• name and address of the importer: use the MSF mission name rather than the name of the medical coordinator to avoid delays if coordinator changes.
• name and address of the exporter: verify with your procurement centre or medical department.
• detailed product description:
• number of units (ampoules, vials, capsules, tablets, oral drops, oral solution, patches or rectal tubes)
• quantities written in both words and figures
• exact dosage, volume, and total active ingredient content (mg or g).
• Example: one hundred (100) ampoules of fentanyl, 0.05 mg/ml, 2 ml, totalling 10 mg of active ingredient.
• If the product is a salt formulation (e.g. morphine hydrochloride), verify whether the country requires the quantities expressed as the content.
• Example: 40 vials of morphine hydrochloride 10 mg/ml, 1 ml contain 400 mg of morphine hydrochloride, equivalent to 40 x 7.6 mg = 304 mg of morphine base.
• name and signature of the issuing authority, preferably on official letterhead.

Remarks

• Carefully check import permits for errors before submission. Corrections are often impossible after issuance.
• Orders should correspond to full pack quantity as stated on the permit. It is acceptable to import less than what the authorised quantity, but not more.
• Some countries require additional information or documents such as manufacturer details, Certificate of Analysis, cGMP, Proforma invoice, etc.) as this is important for the procurement centre re-order process (if stock (picking) reservation is required for example).
• Some countries require a general import permit before applying for a Special Import Permit (regulated items) (e.g. Ethiopia and Nigeria)
• A scanned copy of the import permit may be sent initially to the procurement centre to begin the export permit process, followed by the hard copy. Some countries require the hard copy to be returned after after obtaining the export permit (e.g. Uganda).
• The MSF procurement centre uses the import permit to apply for the export permit through its national authorities. An import permit can generally only be used once.
• Consult your procurement centre website for guidance regarding:
• substances requiring export licence
• grouping multiple drugs on one import permit
• number of orders per mission (usually one order for the whole mission instead of one per project, and preferably annually due to the time to obtain the import/export permits)
• procedures for submitting permits.
• Import permits must be sent directly to your procurement centre, not the NMRA.

Exporting country (where the order is placed)

Follow the instructions on the website of your procurement centre:

MSF Supply:

• https://extranet.msfsupply.be/article_stupefiant.php

MSF Logistique:

• https://msfintl.sharepoint.com/sites/SP-BDX-msflog-op-general-info/products-information/chemical-precursors
• https://msfintl.sharepoint.com/sites/SP-BDX-msflog-op-general-info/products-information/psychotropic-narcotic-classified-products

Exceptional cases

In certain situations (e.g., civil war, guerrilla-controlled areas, or where the competent authority is non-functional or not member of the INCB), normal import procedures may not be possible.

Examples include:

• countries with no longer operational authorities (e.g. South Sudan)
• local competent authority under other authorities and are unable to issue internationally recognised permits (e.g., KMCA-Kurdistan Medical Control Agency for Iraq is under Baghadi authorities)

In these situation, the responsible pharmacist at the European Supply Centre may negotiate with its Ministry of Health and the International Narcotic Control Board (INCB) in Vienna.

This may allow export of limited quantities of controlled drugs under the WHO Emergency Authorisation Procedure. This mechanism may also be used during emergencies such as natural disasters.

A written request signed by the medical director of the MSF operational centre should be sent to the pharmacist responsible for controlled medicines at the MSF procurement centre.

The medical coordinator must promptly acknowledge receipt of the shipment for reconciliation with the supply centre NMRA.

Transportation of narcotic and psychotropic drugs to missions

These products are generally transported by air because import permits are usually valid for a limited period (commonly three months or slightly longer). The shipment must arrive in the destination country before the import permit expires.

Controlled Substances in the Kits

For each kit, a specific module is created for regulated drugs (code ending with "C"). However, this module is not supplied automatically when the kit is ordered.

These regulated products are not included in the kit or module and must be ordered separately. An import permit for each regulated drug must be sent to the procurement centre.

Note:

• This applies only to medical items regulated at the supply centre level (i.e. products requiring an export permit in the EU).
• If a product is regulated only in the destination country (e.g. narcotic, psychotropic, or precursor), it may not be automatically separated into a dedicated module in the kit. It is therefore the responsibility of the mission to review the kit contents using the detailed Medical Kit List available on the MSF Catalogue.

Storage and Handling of Regulated Products in the field

It is essential to comply with the list of regulated drugs and legal requirements of the country where MSF operates, as MSF is not exempt from national legislation. MSF pharmacies may be inspected by health authorities, particularly because MSF works with national staff.

General rules

• Identify regulated drugs: confirm wich products are considered "regulated drugs” by national authorities, as the list may differ between countries.
• Designate responsible personnel: appoint 2 or 3 members responsible for the handling, movement and tracking of regulated products.
• Maintain written records: all pharmacies should keep an updated written list of regulated drugs.
• Ensure secure storage:
• regulated drugs must be stored securely under lock and key, in accordance with national regulations and under the responsibility of designated staff.
• products included in a kit should remain identifiable by the kit name.
• Ensure proper handling: double-check all handling steps, including reception, packing, authorisation, dispatch, and distribution.
• Apply the FEFO principle: "First Expired First Out" (FEFO) principle applies to regulated drugs. Expiry dates should be checked regularly, especially for drugs in kits.
• Track and report stock movements:
• record all movements of regulated drugs in a dedicated register.
• national health authorities may require regular written reports on stock movements and consumption.
• ensure all required documentation is completed and officially maintained.

The deterioration of medicines depends on various factors, including the product type, manufacturing process, quality of raw material, excipients, and other factors. Storage conditions also play a significant role.

The shelf life of a product is determined based on an average rate of deterioration under standard conditions of temperature, humidity, and light, as specified by the International Conference on Harmonisation (ICH) for the climatic zone where the medicine will be marketed.

The expiry date is set to ensure that, under these conditions, therapeutic effectiveness remains unchanged (at least 90% of the active ingredient must be still be present), and there is no significant increase in toxicity.

Quality is defined as “the suitability of a pharmaceutical product for its intended use”. Each medicine intended for patient use must meet acceptable quality standards, including identity, purity, safety, and efficacy.

If a medicine fails to meet quality standards, the consequences can include:

• lack of therapeutic effect, potentially leading to prolonged illness or death;
• toxic or adverse reactions;
• wastage of financial resources, and
• loss of patient confidence

The quality of pharmaceutical products is affected by raw materials, the manufacturing process, packaging, transport, and storage conditions. These influences may accumulate over time.

Stability is defined as “the extent to which a product retains, within specified limits, and throughout its period of storage and use (i.e., its shelf-life), the same properties and characteristics as it had at the time of manufacture” (USP 37).

Expiry date

Even when stored under proper conditions, medicines naturally deteriorate over time due to various processes.

In many countries, manufacturers are legally required to study the stability of their products under standardised and exaggerated environmental conditions. These studies help manufacturer select the optimal formulation, packaging, storage conditions, and ultimately determine an expiry date for each dosage form in its packaging.

The manufacturer’s expiry date refers to the expiry date of the unopened container.

The International Conference on Harmonisation (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use guidance document defines shelf life as: “The period of time during which a pharmaceutical product is expected to remain within the approved shelf-life specification, provided it is stored under the conditions defined on the container label.”

Most pharmaceutical products have a shelf-life of 3 to 5 years. Products containing less stable substances are usually guaranteed for only 1 or 2 years.

A practical definition of shelf-life is: the time between the date of manufacture and the expiry date.

For products sent to the field, the remaining shelf-life should be at least 1/3 of the total shelf-life. This means that ine third of the shelf-life should remain at the time the product is released from stock. Note: transport and handling may take additional time).

For medical kits, which often only have 6 months of remaining shelf-life, they should only be ordered for emergency situations and not for EPREP stock.

The expiry date is clearly indicated on both primary (immediate) packaging and secondary packaging:

The UK MHRA advices pharmaceutical manufacturers that the term ‘expiry date’ means the product should not be used after the end of the month stated. For example, an expiry date of 12/2025 means the product should not be used after 31 December 2025.

On the other hand, the UK Royal Pharmaceutical Society (RPS) clarifies that when a product is labelled ‘Use by’ or ‘Use before’, it means the product should be used before the end of the previous month. For example, ‘Use by 06/2025’ means the product should not be used after 31 May 2025.

Caution

It is important not to confuse the date of manufacture with the expiry date (“Exp. Date”).

Shelf-life and In-Use shelf-life

Once a multi-dose drug container is opened, the exposure of the drug to environmental factor can shorten its shelf-life. Repeated opening and closing of the container may increase the risk of microbiological contamination and/or physico-chemical degradation. This risk is particularly high in bulk packaging and for certain medicines, such as anti-tuberculosis medicines, which are sensitive to temperature and humidity.

Some oral or injectable multi-dose products are provided in powder form tat needs to be reconstituted before use. After reconstitution, these products may undergo significant hydrolysis and thus have a limited shelf-life. Some may require refrigeration.

For non-sterile medicines, always consult the manufacturer's leaflet for information on the in-use shelf-life. If such information is provided, follow the manufacturer’s guidance. If not, refer to the table below.

Always record the date the product was opened and the updated expiry date on the medicine label or, if there is insufficient space, on the outer packaging.

-

Notes:

• Sterile products: any remaining content should be discarded immediately after the first use.
• Ointments: these are semi-solid, greasy preparations intended for application to the skin or mucous membranes.
• Creams: these are similar to ointments but contain an aqueous phase, making them more susceptible to microbiological contamination.
• Use of jars: a 100 g jar is intended for individual use. A 500 g jar can be used for multiple patients, for example, in an hospital ward, but carries an increased risk of contamination.

Basic storage guidelines

Proper storage is essential for maintaining the effectiveness and safety of medicines, as they can be sensitive to environment factors such as light (especially sunlight), oxygen, moisture, and extreme temperatures.

MSF follows manufacturer's storage recommendations in alignment with WHO GDP Guidelines and MSF transport policy

• Keep medicines in their original containers and outer packaging to protect them from sunlight.
• Ensure containers are tightly closed to prevent exposure to air and moisture.
• Avoid opening containers before use.
• Do not remove desiccant packets (e.g. silica gel) from the packaging, as they help control moisture levels.
• Always check and respect expiry dates - do not cover them with labels or writings.
• Store medicines according to the manufacturer's instructions.
• Follow the FEFO (First Expired, First Out) principle for stock management.
• Organise cartons properly, ensuring that arrows point upward and that identification labels, expiry dates, and manufacturing dates are clearly visible.

Protecting products from sunlight

• Cover windows or use curtains to block direct sunlight exposure.
• Store products in their original packaging and in cartons.
• Avoid storing or packaging products in direct sunlight.
• Use opaque plastic or dark glass bottles for products that are specifically sensitive to light.
• Maintain trees around the facility to provide natural shade, but regularly check for any branches that could potentially damage the facility.

Temperature storage for medical consumables

• Store frozen: products that require storage at temperatures of -20ºC, such as certain vaccines, should be transported in a cold chain and stored frozen, typically for longer-term storage at higher-level facilities.
• Store refrigerated: store products at a temperature between 2°C and 8°C. This range is suitable for products that are heat sensitive but should not be frozen, such as vaccines. (For further information see Vaccines family).
• Keep cool: store products between 8°C and 15°C. This is for products that need to be kept cool but are not as temperature-sensitive as those requiring refrigeration.
• Store at room temperature: store products at a temperature between 15°C and 25°C. This is the standard temperature range for most of medical products.
• Store at ambient temperature: while not widely used, this term refers to normal storage conditions. Ambient temperatures typically means “room temperature”, ranging from 15°C to 25°C or up to 30°C, depending on local climate conditions. It implies storage in a dry, clean, and well-ventilated area.

Measures to reduce effects of humidity

• Ventilation: ensure proper airflow by opening windows (with screens and bars) or using air vents. Store products on pallets and maintain space between pallets and walls.
• Secure lids: make sure all container lids are securely closed to prevent moisture from entering.
• Air circulation: use fans to improve airflow and reduce humidity build-up.
• Air conditioning: use air conditioning to control temperature and humidity levels.

Monitoring temperature and humidity in the medical storage area

• Manual monitoring: temperature and humidity should be manually checked twice a day, including on weekends
• Electronic monitoring instruments: use electronic devices for continuous monitoring that can record and track temperature and humidity over time, including minimum and maximum readings. To be monitored twice daily as well.
• Importance of manual checking: while remote monitoring systems are valuable, they should not replace the twice daily manual checks.

Deterioration of medicines

Medicines can deteriorate even before their expiry date, particularly if they have been stored under inappropriate conditions (e.g. excessive temperature, humidity, or light exposure) differing from those used during stability testing.

Excessive or accelerated deterioration may also result from initial quality defects, such as manufacturing issues. It is therefore important to be familiar with the normal appearance and characteristics of each medicine (colour, odour, solubility, consistency) to detect any signs of deterioration.

Some forms of deterioration may not produce visible changes, any physical or visual abnormalities should be closely monitored. Any medicine showing signs of deterioration must be discarded, regardless of its expiry date. In case of any doubt, contact the pharmacist for advice.

Common signs of deterioration

• All products: broken or ripped packaging, missing, incomplete or illegible labels.
• Liquids: discolouration, cloudiness (turbidity), sediment or unsuspended particles, broken seals on bottles, cracks in ampoules, bottles or vials, moisture in packaging.
• Light-sensitive products: torn or damaged packaging
• Tablets: discolouration, crumbling, missing tablets in blisters, stickiness (especially for coated tablets), unusual odour.
• Capsules: discolouration, stickiness, crushed capsules
• Injectables: liquid that fails to return to suspension after shaking.
• Tubes: stickiness, leaks, perforations or holes in the tube.
• Sterile products: torn or ripped packing; missing or broken parts; moisture inside packaging; stains on packaging.
• Foil packaging: perforations or holes.
• Suppositories, pessaries, creams and ointments: melting, separation of phases.

Use of expired or deteriorated drugs

MSF does not recommend the use of expired or damaged medicines due to the significant risk for the patient safety.

Destruction of expired and/or deteriorated drugs medicines

Expired or deteriorated medicines must be removed from all usable stock and stored in a designated, locked area, pending destruction.

Before proceeding with destruction, contact your medical department to determine the most appropriate method based on the specific context. Improper destruction can be hazardous!

Check local regulations regarding medical waste management and environmental protection before implementing any disposal method.

Proper disposal is critical, as incorrect disposal can result in serious negative consequences, including:

• water contamination
• diversion and illegal resale of expired or inactive medicines
• release of toxic pollutants into the air due to improper incineration.

Particular attention must be given to the disposal of specific categories of pharmaceuticals, including:

• controlled substances, e.g., narcotics and psychotropic drugs;
• anti-infective drugs;
• cytotoxic (anti-cancer) drugs;
• toxic drugs;
• aerosols;
• antiseptics and disinfectants.

MSF must normally obtain authorisation for destruction from the relevant local authorities and ensure that the destruction method complies with both WHO and MSF guidelines, as these may differ from local regulations (if any).

In specific cases, such as batch recalls, MSF must also obtain a certificate of destruction.

Introduction

The WHO defines packaging as a collection of components (e.g. bottles, vials, closures, caps, ampoules, or blisters) that surround the pharmaceutical product from production until its use¹. The US FDA defines the container closure system (CCS) as the combination of packaging components that work together to contain and protect the dosage form. This includes both primary and secondary packaging components, with the latter intended to provide additional protection to the drug product².

Any proposed packaging system must be proven to be suitable for its intended use. It should:

• adequately protect the dosage form against light, moisture, oxygen, contaminants, and other external factors;
• be compatible with the dosage form, without causing adsorption or degradation of the active pharmaceutical ingredient;
• be made from materials considered safe for the dosage form and its route of administration, without migration of potential toxic substances;
• function as intended, including any required performance features.

Child-resistant closures are designed to make it difficult for young children to open medicine packaging while still allowing appropriate access for adults. Child-resistant packaging has been shown to reduce child mortality linked to intoxication from oral prescription medicines. The three most common common types of reclosable child-resistant closures are “press-turn”, “squeeze-turn” and combination-lock systems (WHO TRS 902).

Tamper-evident packaging refers to packaging where access to the product is impossible without visible destruction of the seal or part of the packaging (USP 659). It “provides visible evidence to consumers that tampering has occurred” (WHO 902). Examples of packaging technologies that may meet tamper-resistant packaging requirements are described in “FDA Compliance Policy Guide, 7132a. 17, CPG Sec. 450.500 Tamper-Resistant Packaging Requirements for Certain Over-the-Counter Human Drug Products”.

¹ WHO, TRS 902, Annex 9

² USFDA, Container Closure Systems for Packaging Human Drugs and Biologics

Container closure systems for specific pharmaceutical forms

Container closure systems for parenteral preparations (DINJ and DINF)

Parenteral pharmaceutical products are sterile preparations. They are typically liquids, such as solutions, emulsions, or suspensions, or dry solids that must be reconstituted with an appropriate vehicle before administration. They are classified as:

• small-volume parenterals -SVPs: volumes of 100 ml or less
• large-volume parenterals -LVPs: volumes greater than 100 ml.

Small-volume parenterals (DINJ) may be packaged in:

• disposable cartridges;
• disposable syringes;
• vials;
• ampoules;
• flexible bags;
• semi-rigid bottles.

Only single-ended ampoules are accepted by MSF.

Cartridges, syringes, vials, and ampoules are usually made of Type I or Type II glass, or polypropylene. Specific glass requirements for each pharmaceutical form are described in the European Pharmacopoeia (EP), British Pharmacopoeia (BP), or United States Pharmacopoeia (USP).

Stoppers and septa used in cartridges, syringes, and vials are usually made from elastomeric materials. Closures for injectable preparations must comply with the relevant Type I or Type II test limits defined in the EP or USP, depending on whether the preparation is aqueous or non-aqueous.

Caps or over seals are used to secure the rubber closure to the container and maintain seal integrity during transport, handling, and storage throughout the product's shelf-life. These caps are usually made of aluminium and may include a plastic top to make opening easier. Caps also provide evidence of tampering.

Large-volume parenterals (DINF) may be packaged in:

• flexible bags, with or without PVC;
• semi-rigid bottles;
• glass bottles.

MSF's first choices arePVC-free flexible bags or semi-rigid bottles. PVC-containing containers are no longer accepted.

Containers for large-volume parenterals must include:

• a site suitable for attachment of an infusion set;
• a site allowing the administration or addition of medicines.

Flexible bags are typically made from multi-layer plastic materials.

Cyclo-olefins may be used as an alternative to PVC or glass. They are flexible and have low permeability.

Flexible bag ports, used for medication addition and administration, are usually made from plastic and/or elastomeric materials. These bags generally include a hanging part designed to withstand tension during use.

Depending on the plastic used, IV fluid bags may have a protective pouch or overwrap that protects against:

• solvent loss, which may increase concentration;
• oxygen ingress;
• dust.

The overwrap is made from material with low permeability to water and gases.

Semi-rigid plastic bottles are often manufactured using Blow-Fill-Seal (BFS) technology and may have a sealed top fitted with different types of closures. Some manufacturers also provide open-neck bottles fitted with rubber stoppers and flip-off caps.

BFS bottles with a nipple head are not appropriate. The base of the nipple head is fragile, and the small cap does not provide adequate protection, which may create fatigue points and micro-holes during transport. These bottles also lack a dedicated injection or administration site, requiring the top of the nipple to be pierced by the IV set or needle. Where an alternative is available, experts recommend using bottles with larger caps to provide better head protection.

Euro-headcaps are acceptable but present some risks, including:

• possible contamination of the top before welding if not handled in an aseptic environment;
• potential failure to sterilise the space between the bottle top and cap if water vapour penetration os insufficient.

Newer-generation caps usually have two access ports: one for the IV set and one for admixture. These ports are typically protected by an aluminium seal or plastic cover, such as Twincap^® or Duocap^® systems.

Container closure systems for ophthalmic products (DEXO)

Ophthalmic preparations are sterile products designed for application to the eye. They may be available in liquid, semi-solid, or solid forms.

They include:

• eye drops:
• eye lotions;
• semi-solid eye preparations;
• ophthalmic inserts.

Liquid preparations for ophthalmologic use are typically packaged in sterilised single-dose (often preservative-free) or multi-dose containers.

Multi-dose products are most commonly packaged in polyethylene (PE) or polypropylene (PP) bottles with an integrated dropper on the neck. These are sometimes called "droptainers". For some eye drops, glass containers may be used when there are stability or compatibility concerns with flexible plastics.

The container must be tamper-evident and contain a maximum of 15 ml of preparation.

Single-dose containers are generally made from polypropylene and manufactured using Blow-Fill-Seal (BFS) technology.

Some preparations may be indicated for both ophthalmic and otic use (e.g., DEXTCIPR1D- : a preparation for eye and/or ear administration).

Semi-solid eye preparations are packaged in small, collapsable sterilised tubes, with or without an ophthalmic cannula or tip. These tubes are typically made from metal. Ophthalmic ointments that react with metal may be packaged in tubes with an internal epoxy or vinyl plastic coating. The packaging must be tamper-evident and contains no more than 5 g of preparation³.

³ USFDA, Container Closure Systems for Packaging Human Drugs and Biologics.

Containers for topical products⁴ (DEXT)

Topical dosage forms include:

• aerosols;
• creams;
• emulsions;
• gels;
• lotions;
• ointments;
• pastes;
• powders;
• solutions;
• suspensions.

These products are generally intended for local, non-systemic effects and are usually applied to the skin or oral mucosa. Topical products may also include certain nasal, ear, vaginal and rectal preparations.

Semi-solid or liquid preparations are commonly packaged in multi-dose containers, such as jars or collapsible tubes.

Flexible, collapsible tubes are usually made from metal or metal-lined materials, LDPE, or laminated materials. These tubes may be closed-ended or open-ended. In closed-ended tubes, the product does not come into contact with the cap during storage.

Jars are usually made of polypropylene and have a screw cap. Similar cap liners and inner seals may be also be used for solid oral dosage forms.

Nasal, otic, vaginal, and rectal preparations should be packaged in containers suitable for administration at the intended application site. Where needed, they should be supplied with an appropriate applicator.

Closures should be designed to minimise the risk of microbial contamination and should be tamper-evident.

Liquid ear preparations⁵ are supplied in multi-dose containers made from glass or suitable plastics. These containers often have an integrated dropper or a screw cap from appropriate materials. They may also include a rubber dropper or plastic teat, sometimes supplied separately.

Vaginal and rectal products are usually packaged in aluminium/aluminium strips or blisters, or occasionally in tubes (e.g., vaginal gel).

⁴ WHO, TRS 902 Annex 9 ; Handbook of Pharmaceutical Manufacturing Formulations: Liquid Products, Sarfaraz K Niazi, CRC Press, 2009
⁵ Ph Eur monograph 0652, Ear Preparations

Containers for oral medicines (DORA)

Liquid oral dosage forns⁶, such as solutions, syrups, or suspensions, require protection from:

• solvent loss;
• microbial contamination;
• exposure to light , where relevant;
• reactive gases, such as oxygen, where relevant.

These liquid dosage forms may be supplied in multiple-dose containers, such as bottles, or in single-dose containers, such as sachets.

Bottles are usually made of glass or plastic (e.g., PET or HDPE). They often have a screw cap made from aluminium or polypropylene, with a liner. They may also include a tamper-resistant seal or an over cap welded to the bottle.

Each dose from a multi-dose container should be administered using a suitable measuring device, such as:

• a measuring cup;
• a dosing spoon, generally for volumes of 5 ml or more;
• an oral syringe;
• a dropper.

Many associated dosing components are graduated. Graduations should be clearly legible and indelible.

Pouches may be made from single-layer plastic or laminated material.

Solid oral dosage forms, such as tablets and capsules, as well as powders for reconstitution, generally require protection from moisture and water vapour.

Typical containers include bulk containers, strips, blister packs and sachets.

Bulk containers are plastic or glass bottles with screw or snap closures.

Glass containers are generally made of type III glass. Plastic containers are most often made from HDPE, PP, or PET. In some cases, the primary packaging may be an LDPE bag placed inside an HDPE or polypropylene bottle to provide additional protection.

A typical closure consists of a cap, often made of polypropylene, and may include a sealed part. The seal is a piece of material placed between the cap and the bottle. Different liner materials can be used to provide a moisture barriers, chemical resistance, or leakage prevention.

The seal can also provide tamper evidence. Once removed, it cannot be reapplied to the container.

Filler material may be added to the container to fill empty spaces and prevent tablets from breaking during transport. Fillers can be made of cotton, rayon or polyester.

A desiccant may be used to reduce moisture in the head space of the bottle and to protect gelatin capsules or moisture-sensitive products. The desiccant’s shape and size should be clearly distinguishable from the medicine to prevent accidental consumption. Desiccants are usually packed in a small HDPE canister or sachet and should be placed on top of the tablets.

A bulk container should not contain more than 1,000 tablets.

Strips are multi-dose containers consisting of two layers of aluminium, usually with perforations. They are suitable for containing single doses of solid or semi-solid preparations⁷.

Blisters are multi-dose containers consisting of a moulded film that contains the product and a cover material that seals the blister.

Different blister-film materials and combinations are available on the market, offering varying degrees of protection against water vapour, gas and light⁸. Because PVC film has limited barrier properties, multi-layer PVC-based films are often used when better moisture protection is required. Examples include PVC coated with PVDC (polyvinylidene chloride), PVC laminated with PCTFE (polychlorotrifluoroethylene, or Aclar®), triplex laminates made of PVC/PE/PCTFE.

The lid stock is sealed to the moulded blister. It is usually a laminate that includes a barrier layer, such as aluminium foil.

Sachets are suitable packaging for single-dose oral powders. Each dose is enclosed in an individual sachet, preferably made from laminated aluminium foil, with edges sealed by heat or adhesive.

⁶ USFDA, Container Closure Systems for Packaging Human Drugs and Biologics; USP <659> Packaging and storage requirements

⁷ WHO, TRS 902 Annex 9

⁸ USP <1146> Packaging practice—repackaging a single solid oral drug product into a unit-dose container

Pharmaceutical products for inhalation (DORA)

Preparations for inhalation are intended to be administered as vapours or aerosols into the lung to obtain a local or systemic effect. These products may be supplied in multi-dose or single-dose containers ⁹.

Inhalation pharmaceuticals include:

• Aerosols in pressurised metered-dose devices: the preparation is released from the container as an aerosol when an appropriate valve is activated.
• Liquid preparations for inhalation: these are administered using nebuliser and are usually packaged in polypropylene single-dose containers.
• Inhalation powders: these are delivered using dry powder inhalers. The inhalers may be loaded with pre-dispensed powders in capsules or other suitable dosage forms, or may contain a powder reservoir with a metering mechanism
• Nasal sprays: these are designed for nasal administration

⁹ Ph Eur monograph 0671: Preparations for inhalation; USFDA, Container Closure Systems for Packaging Human Drugs and Biologics.

Non-contact infrared thermometers (NCITs) can be used to measure temperature rapidly and non-invasively

These NCITs were introduced into the MSF lists solely as a means of rapidly screening people during the Ebola outbreak in West Africa. There are not intended to replace the standard clinical thermometer. According to the literature, and MSF experience, reliability of these devices is an issue, an accuracy can easily be reduced by environmental conditions and the way the measurement is taken. They cannot be used to check the vital signs of a patients, but they are a practical screening tool.

There are no consumables (except the batteries) and no accessories (maybe a case / pouch for storage of the device

GMDN

• Code : 17888
• Name : Infrared patient thermometer, skin
• Definition: A hand-held, battery-powered, electronic instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.

NCITs are non standard articles, currently 3 models are used in MSF projects

EEMDTISE3— INFRARED THERMOMETER, skin (Thermoflash LX26)

• Manufacturer: Visiomed technology, Shenzhen, China
• Issues noticed by MSF users: problem with the accuracy of the measurement, requires to wait 1 min between each measurement
• Range: 32.0 to 42.9°C
• Accuracy = 0.2°C
• Resolution: 0.1°C
• Distance measure = 2-5 cm
• Automatic shutdown, 5 sec
• CE marked (NB0197)

EEMDTISE4— INFRARED THERMOMETER, skin no contact (EX-IR200)

• Manufacturer : Extech
• Range: 32.0 to 42.5°C
• Accuracy = 0.3°C
• Resolution: 0.1°C
• fast response (0.5 seconds)
• measurement distance: 5 - 15 cm
• memory = 32 readings
• 2AA batteries + pouch

EEMDTISE5— INFRARED THERMOMETER, skin (Masimo TIR-1)

• Range: 34.4 to 42.2°C
• Accuracy = 0.2°C (36-39 °C), 0.3°C above and below that.
• Resolution: 0.1°C
• fast response (1 second)
• measurement distance: 1.2 - 5 cm
• memory = 30 readings
• Bluetooth connectivity
• 2AA batteries

CHECKLIST

• Legal manufacturer
• Name + Address clearly visible on package
• Website available (check)
• Known manufacturer?
• Availability of QA docs
• CE marking:
• check if CE marking is correct
• NB identification (MD Class IIa): If no NB identified: article not registered as MD
• Registered in other HRC
• check GUDID if the device is listed (use manufacturer + brand/model as terms)
• Availability of a technical sheet, reference to a national / international standard?
• Battery powered, 2AA batteries is most common, but they sometime use the rectangular 9V battery (PP3), or AAA batteries (much shorter autonomy)
• Specifications: check IFU
• Range: 32 – 43 °C
• Temp in °F or °C possible
• Accuracy: 0.2 – 0.3 °C
• Distance for measuring: 3 – 5 cm most common, some 5 – 15 cm
• Response in 0.5 – 3 seconds
• Presence of alarms are practical but not essential, alarms can be audible or visible (often a traffic light system)
• Bluetooth connectivity: limited added value (often limited to a specific range of devices)
• Practical use of the device
• Screen of practical size, letters / numbers can be read easily, also with poor light or in bright sunlight
• Change of temperature reading from °F to °C is possible
• Time needed to get the reading of temperature
• Check distance of measuring: minimum and maximum as stated in IFU
• Waiting time between two readings?
• Automatic shutdown after 1-15 minutes, to save the batteries, > 20 minutes = batteries may not last long.
• If alarms present, settings can be adjusted
• Device is not heavy (can be operated by one person during a relatively long period)
• Can be operated using (examination) gloves
• Compare readings with results obtained with other thermometers (limited value, intended use = screening)

Benefits of NCITs

• Non-contact approach may reduce the risk of spreading disease between people being evaluated
• Easy to use
• Easy to clean and disinfect
• Measures temperature and displays a reading rapidly
• Provides ability to retake a temperature quickly

Limitations of NCITs

• How and where the NCIT is used may affect the measurement (for example, head covers, environment, positioning on forehead).
• The close distance required to properly take a person’s temperature represents a risk of spreading disease between the person using the device and the person being evaluated.

Proper Use of NCITs

• The person using the device should strictly follow the manufacturer’s guidelines and instructions for use for the specific NCIT being used.
• Use in a draft-free space and out of direct sun or near radiant heat sources.
• Typically, the environmental temperature should be between 16-40 ºC and relative humidity below 85 percent.
• Place the NCIT in the testing environment or room for 10-30 minutes prior to use to allow the NCIT to adjust to the environment.
• The test area of the forehead is clean, dry and not blocked during measurement.
• The person’s body temperature or temperature at the forehead test area has not been increased or decreased by wearing excessive clothing or head covers (for example headbands, bandanas), or by using facial cleansing products (for example cosmetic wipes).
• Hold the NCIT sensing area perpendicular to the forehead and instruct the person to remain stationary during measurement(s).
• The distance between the NCIT and forehead is specific to each NCIT. Consult the manufacturer’s instructions for correct measurement distances.
• Do not touch the sensing area of the NCIT and keep the sensor clean and dry.

More info online:

• https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/non-contact-infrared-thermometers
• https://www.cebm.net/2020/08/screening-for-covid-19-with-infrared-thermometers-more-marketing-than-medical-evidence/
• https://www.businesswire.com/news/home/20200803005329/en/Non-Contact-Infrared-Thermometers-Market-2020-2030-COVID-19-Implications
• https://pubmed.ncbi.nlm.nih.gov/21651612/#:~:text=The%20sensitivity%20and%20specificity%20for,avoid%20unnecessary%20laboratory%20work%2Dup.
• https://www.community.healthcare.mic.nihr.ac.uk/reports-and-resources/horizon-scanning-reports/hs-report-0025

Under COVID-19 times, the procurement and validation of locally purchased Personal Protective Equipment items is becoming under pressure. Despite the pressure, we must still make sure we provide the best levels of protection to staff and patients. Often, we hear that masks are fake, there is no such item as a fake mask, there are copies, counterfeits and many different qualities. MSF provide staff and patients with the best quality PPE, but sometimes it is very difficult to tell between a good mask and a bad one. To assist with the local procurement process and to ease the pressure, a field-testing protocol has been developed to provide useful information to ease the exceptional validation process.

This testing protocol comes as a complement to the quality documentation assessment including the review of the packaging, certificates and test reports when available. The reason these masks require testing is because there is doubt about their quality, origins, and/or because the quality cannot be verified by other means (certificates, unknown manufacturer, etc).

Please follow the local purchase validation procedure in place in your OC and contact your OC Medical Device / pharma referent if you have any questions.

• Material needed. A marker, a pair of scissors, a lighter and a bottle of water
• Mask Selection. Take 6 Masks from 3 separate boxes, do not take them all from the same box and it is always best to take them from the middle of the box, not just the tope one.
• Numbering. Number the Masks 1-6 using a pen on the outside and inside. These number will be used to record the details of your finding.

General Test

Check the stitching or bonding, does it look tight, professional, neat, cover the month and nose, no loose threads, strap bonded okay, metal nose strip, is it along the full length of the mask, or only a small part. Is it comfortable to wear, is material soft and non-irritating. Masks have 3 layers, coloured on outside, 2 equal straps or ear loops, measured when flat 90 x 175 mm.

If the general test produces very bad results then it is clear the quality of the product is so bad that it cannot be used as any type of surgical masks, only you will be able to see how good or bad it is, and make the assessment based on your findings. Base your decision on the impact of your findings, are there minor faults (small parts of loose stitching or bonding, 1 or 2 areas where stitching has come off) or major (lots of bad quality, missing ear loops, very poor stitching, not very strong). Everything you could possibly find or not find can be listed here. If it is so bad, do not verify and do not send request for exceptional validation.

Score: 1 - Excellent; 2 - Good; 3 - Fair; 4 - Bad; 5 - Very Bad

Static Test

Place some very small pieces of cotton, thread or polystyrene on a table, place the masks on the thread and lift the mask up, some of the thread should stick to the masks because of the static, static is good as it improves the filtration of the masks.

Whilst it is best to have a functional filter in a surgical mask, static test is a lower priority to having a surgical mask as a good barrier between you and others. So, a poor performing static test could still be validated as a Surgical mask, if the static energy does not pick up more than a couple of pieces of thread or polystyrene. Then, it can still be sent forward for exceptional validation. Just make sure the findings are recorded in the record sheet. Even if no pieces are picked up, still useful to send for exceptional validation.

Score: 1 – Excellent, lots of pick up; 2 – Good, some pick up; 3 – Fair, 3-4 pieces picked up; 4 – Bad, only 1-3 pieces picked up; 5 - Very bad, no pieces picked up.

Water Repellent Test

Lay all masks on a clean table in order with the outside facing up, place 3-4 drops of water on the outside of the masks. The water should NOT be absorbed and should remain on the outer layer. If water is absorbed, write how long in seconds it is before the water is absorbed.

This is one of the most important tests for surgical masks, it should be repellent on the outside. If the water is absorbed into the material immediately or within 5 minutes, the mask cannot be used as a surgical mask, FAIL overall. If the water is absorbed after 5 minutes, note this in the record sheet, the mask might still be able to be used with other measures, for example using a face shield, not high-risk areas or after a specific period of time.

Score: Water absorbed: 1 - in more than 10 Minutes; 2 – in 8 minutes; 3 – in 6 minutes; 4 – in 5 minutes; 5 – in less than 5 minutes

If water is absorbed immediately, the test is a fail and the mask cannot be validated for medical or surgical use.